{"id":3095,"date":"2020-06-22T15:19:00","date_gmt":"2020-06-22T13:19:00","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=3095"},"modified":"2021-05-11T17:49:22","modified_gmt":"2021-05-11T15:49:22","slug":"modules","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/","title":{"rendered":"Modules"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7djxavr-025f170734c7685164d22d6d4ebca443\">\n.avia-section.av-7djxavr-025f170734c7685164d22d6d4ebca443{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/shutterstock_682989595-1.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-7djxavr-025f170734c7685164d22d6d4ebca443 .av-section-color-overlay{\nopacity:0.4;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-7djxavr-025f170734c7685164d22d6d4ebca443 header_color avia-section-no-padding avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7bbs553-f7fa9ba0410b4e49039e828b26e940cb\">\n#top .hr.hr-invisible.av-7bbs553-f7fa9ba0410b4e49039e828b26e940cb{\nheight:500px;\n}\n<\/style>\n<div  class='hr av-7bbs553-f7fa9ba0410b4e49039e828b26e940cb hr-invisible  avia-builder-el-1  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7auvn9z-b694740a2a93bed5a60ccee3a8e469b3\">\n.avia-section.av-7auvn9z-b694740a2a93bed5a60ccee3a8e469b3 .av-extra-border-element .av-extra-border-inner{\nbackground-color:#ffffff;\n}\n<\/style>\n<div id='technical_documentation'  class='avia-section av-7auvn9z-b694740a2a93bed5a60ccee3a8e469b3 main_color avia-section-default avia-no-shadow  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-scroll av-arrow-down-section container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-78ckm8n-68094d8fbeec6ab3ab606fe0e5f9a9b8\">\n#top .av-special-heading.av-78ckm8n-68094d8fbeec6ab3ab606fe0e5f9a9b8{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-78ckm8n-68094d8fbeec6ab3ab606fe0e5f9a9b8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-78ckm8n-68094d8fbeec6ab3ab606fe0e5f9a9b8 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-78ckm8n-68094d8fbeec6ab3ab606fe0e5f9a9b8 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  el_before_av_one_half  avia-builder-el-first '><div class='av-subheading av-subheading_above'><p>BAYOOSOFT Risk Manager<\/p>\n<\/div><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >The efficient route to technical documentation<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div class='flex_column_table av-76upj53-8c7df15300c99f2840b42af7b00b111f sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-76upj53-8c7df15300c99f2840b42af7b00b111f\">\n.flex_column.av-76upj53-8c7df15300c99f2840b42af7b00b111f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-76upj53-8c7df15300c99f2840b42af7b00b111f av_one_half  avia-builder-el-4  el_after_av_heading  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><section  class='av_textblock_section av-po10yv-90a6f7268bc29db9caf866454607d90f '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager is the validated approval accelerator for conveniently generating auditable technical documentation for medical devices. The globally leading medical device manufacturer has been providing support with a process-oriented approach in the preparation of risk management documents according to <a href=\"\/en\/modules-features\/modules\/#risk-management-iso14971\">ISO 14971<\/a>, in usability engineering according to <a href=\"\/en\/modules-features\/modules\/#usability-engineering-en62366-en60601-1-6\">IEC 62366<\/a>, the creation of conformity reports according to <a href=\"\/en\/modules-features\/modules\/#medical-electric-equipment-60601-1\">IEC 60601-1<\/a> as well as the fulfillment of the essential requirements of <a href=\"\/en\/modules-features\/modules\/#essential-requirements-mdr-ivdr\">MDD, IVDD, MDR and IVDR<\/a> since 2000. At the same time, BAYOOSOFT Risk Manager includes fully integrated <a href=\"\/en\/modules-features\/modules\/#requirements-engineering-traceability\">requirements engineering<\/a>, which significantly simplifies the traceability of requirements. For clinics and hospitals, we offer an extension module for medical IT networks according to <a href=\"\/en\/modules-features\/modules\/#medical-it-networks-iec80001-1\">IEC 80001-1<\/a>. In order to provide even greater support in the preparation of technical documentation, the extension modules for <a href=\"\/en\/modules-features\/modules\/#clinical-evaluation\">Clinical Evaluation<\/a> and support in the software lifecycle process according to <a href=\"\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304\">IEC 62304<\/a> are also available.<\/p>\n<p>Validated as category-four software according to GAMP 5, BAYOOSOFT Risk Manager offers a <a href=\"\/en\/modules-features\/modules\/#gamp5-validation\">Pre-Validation Package<\/a> for support with system validation required in your environment. <a href=\"\/en\/modules-features\/modules\/#advanced-reporting\">Advanced Reporting<\/a> as well as a <a href=\"\/en\/modules-features\/modules\/#rest-api\">REST API<\/a> are also available for customization and technical integration into the existing system landscape.<\/p>\n<\/div><\/section><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-73768gn-49ecf16e4e96e9edfcceb3c747a38520\">\n.flex_column.av-73768gn-49ecf16e4e96e9edfcceb3c747a38520{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-73768gn-49ecf16e4e96e9edfcceb3c747a38520 av_one_half  avia-builder-el-6  el_after_av_one_half  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-71auj2v-9e3215d0d34d426fe540e34b16f5134a\">\n.avia-image-container.av-71auj2v-9e3215d0d34d426fe540e34b16f5134a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-71auj2v-9e3215d0d34d426fe540e34b16f5134a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-71auj2v-9e3215d0d34d426fe540e34b16f5134a av-styling- avia-align-left  avia-builder-el-7  el_before_av_image  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2896 avia-img-lazy-loading-not-2896 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png\" alt='' title='RISKMANAGER-LOGO-COLOR_II'  height=\"133\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-768x340.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1030x456.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1500x664.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-705x312.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-450x199.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6zsydef-cff789eb723f3ca0856f815491030dfe\">\n.avia-image-container.av-6zsydef-cff789eb723f3ca0856f815491030dfe img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-6zsydef-cff789eb723f3ca0856f815491030dfe .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-6zsydef-cff789eb723f3ca0856f815491030dfe av-styling- avia-align-center  avia-builder-el-8  el_after_av_image  avia-builder-el-last '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4062 avia-img-lazy-loading-not-4062 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager.png\" alt='' title='Modules Risk Manager'  height=\"872\" width=\"1944\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager.png 1944w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-300x135.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-1030x462.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-768x344.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-1536x689.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-1500x673.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-705x316.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Modules-Risk-Manager-450x202.png 450w\" sizes=\"(max-width: 1944px) 100vw, 1944px\" \/><\/div><\/div><\/div><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-p2ns2f-5ac17721c38a7daeeda2b261048fc211\">\n#top .hr.hr-invisible.av-p2ns2f-5ac17721c38a7daeeda2b261048fc211{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-p2ns2f-5ac17721c38a7daeeda2b261048fc211 hr-invisible  avia-builder-el-9  el_after_av_one_half  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<section  class='av_textblock_section av-6wex5jb-d3359c44d0c620fbed1cb9e97853efb3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Learn more about <strong>BAYOOSOFT Risk Manager<\/strong> modules or arrange a consultation for a product presentation straight away. We will be happy to advise you.<\/p>\n<\/div><\/section>\n<div  class='avia-button-wrap av-6vy6g07-f1f398b929edb94837f329a397f4472e-wrap avia-button-left  avia-builder-el-11  el_after_av_textblock  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-6vy6g07-f1f398b929edb94837f329a397f4472e av-link-btn avia-icon_select-no avia-size-small avia-position-left avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Arrange a consultation now\"><span class='avia_iconbox_title' >Arrange a consultation now<\/span><\/a><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><div class='av-extra-border-element border-extra-arrow-down'><div class='av-extra-border-outer'><div class='av-extra-border-inner'><\/div><\/div><\/div><\/div><div id='risk-management-iso14971'  class='avia-section av-6tyf2gn-b2326dd83f1e86e58c2ba6a749a4db41 alternate_color avia-section-default avia-no-shadow  avia-builder-el-12  el_after_av_section  el_before_av_tab_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6s22ahz-83b8d78f27297c629016ef1dda06c275\">\n#top .av-special-heading.av-6s22ahz-83b8d78f27297c629016ef1dda06c275{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-6s22ahz-83b8d78f27297c629016ef1dda06c275 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-6s22ahz-83b8d78f27297c629016ef1dda06c275 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-6s22ahz-83b8d78f27297c629016ef1dda06c275 av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >RISK MANAGEMENT ACCORDING TO DIN EN ISO 14971<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-6q52smv-8e69100d9f3856685d18f34bd8483908 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The internationally valid standard ISO 14971 stipulates a procedure which identifies, assesses, rates and controls hazards associated with medical devices and their accessories, and monitors the effectiveness of these controls. The requirements of this standard on risk management are fully integrated in BAYOOSOFT Risk Manager for preparing compliant risk management documents. The procedure follows a clearly structured approach based on the process steps of the standard:<\/p>\n<p>Here, BAYOOSOFT Risk Manager offers the choice between two risk analysis methods:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#preliminary-hazard-analysis\">Preliminary hazard analysis (PHA)<\/a><\/li>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#failure-mode-and-effect-analysis\">Failure mode and effect analysis (FMEA)<\/a><\/li>\n<\/ul>\n<p>In both cases, you can define global risk templates and set your own individual risk definitions in each project, and even in each version.<\/p>\n<\/div><\/section>\n\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6oyfauv-e7642c69e097678edca0d4223e6dcbbc\">\n.av-tab-section-outer-container.av-6oyfauv-e7642c69e097678edca0d4223e6dcbbc .av-tab-section-tab-title-container{\nbackground-color:#ffffff;\n}\n<\/style>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-tab-section-1'  class='av-tab-section-container entry-content-wrapper main_color av-tab-no-transition   av-tab-above-content  avia-builder-el-15  el_after_av_section  el_before_av_section  tab-section-not-first container_wrap fullsize'  ><div class='av-tab-section-outer-container av-6oyfauv-e7642c69e097678edca0d4223e6dcbbc'><div class='av-tab-section-tab-title-container avia-tab-title-padding-default' role='tablist'><a href='#risk-analysis' data-av-tab-section-title='1' class='av-section-tab-title av-active-tab-title no-scroll av-6nhwvav-c530ae3be1439252b85d3408b671676e av-tab-with-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-1'><span class='av-tab-section-icon' aria-hidden='true' data-av_icon='\ue8bb' data-av_iconfont='entypo-fontello'><\/span><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Risk analysis<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#risk-assessment' data-av-tab-section-title='2' class='av-section-tab-title  av-68rwsl3-e2d0f5a5af928ea6bf75560bf696676b av-tab-with-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-2'><span class='av-tab-section-icon' aria-hidden='true' data-av_icon='\ue8a5' data-av_iconfont='entypo-fontello'><\/span><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Risk assessment: <\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#risk-governance' data-av-tab-section-title='3' class='av-section-tab-title  av-5w2j68n-dc6168c46d935a56c8ec7f5adebd30df av-tab-with-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-3'><span class='av-tab-section-icon' aria-hidden='true' data-av_icon='\ue856' data-av_iconfont='entypo-fontello'><\/span><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Risk governance<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#residual-risk-evaluation' data-av-tab-section-title='4' class='av-section-tab-title  av-5mdlg0n-a22beb67367911e176232d177a6352a7 av-tab-with-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-4'><span class='av-tab-section-icon' aria-hidden='true' data-av_icon='\ue8a5' data-av_iconfont='entypo-fontello'><\/span><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Residual risk evaluation<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#risk-monitoring' data-av-tab-section-title='5' class='av-section-tab-title  av-5bgk50n-fb39bb05087ac93cac481251dd7f86ed av-tab-with-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-5'><span class='av-tab-section-icon' aria-hidden='true' data-av_icon='\ue803' data-av_iconfont='entypo-fontello'><\/span><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Risk monitoring <\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><\/div><div class='avia-slideshow-arrows av-tabsection-arrow' ><a href='#prev' class='prev-slide av_prev_tab_section av-tab-section-slide' aria-hidden='true' data-av_icon='\ue87c' data-av_iconfont='entypo-fontello'  tabindex='-1'>Previous<\/a><a href='#next' class='next-slide av_next_tab_section av-tab-section-slide' aria-hidden='true' data-av_icon='\ue87d' data-av_iconfont='entypo-fontello'  tabindex='-1'>Next<\/a><\/div><div class='av-tab-section-inner-container avia-section-default' style='width:500vw; left:0%;'><span class=\"av_prev_tab_section av_tab_navigation\"><\/span><span class=\"av_next_tab_section av_tab_navigation\"><\/span>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6nhwvav-c530ae3be1439252b85d3408b671676e\">\n.av-layout-tab.av-6nhwvav-c530ae3be1439252b85d3408b671676e{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-1' class='av-layout-tab av-6nhwvav-c530ae3be1439252b85d3408b671676e av-animation-delay-container  avia-builder-el-16  el_before_av_tab_sub_section  avia-builder-el-first  av-active-tab-content __av_init_open ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"1\" data-tab-section-id=\"risk-analysis\"><div class=\"av-layout-tab-inner\"><div class=\"container\"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6kwpo9j-c2cfca59d7fa79df5cc66f8ac5acc348\">\n.flex_column.av-6kwpo9j-c2cfca59d7fa79df5cc66f8ac5acc348{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-6kwpo9j-c2cfca59d7fa79df5cc66f8ac5acc348 av_two_fifth  avia-builder-el-17  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-nk7h2v-3d1fe89abc61df23bc2aaac69aaf2f55\">\n#top .hr.hr-invisible.av-nk7h2v-3d1fe89abc61df23bc2aaac69aaf2f55{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-nk7h2v-3d1fe89abc61df23bc2aaac69aaf2f55 hr-invisible  avia-builder-el-18  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-6ieiaef-d0c750dfb8c1a03f08e20ed64356351b '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The central component of BAYOOSOFT Risk Manager is the <strong>risk management tree<\/strong>, comprising <strong>features, hazards, causes and measures<\/strong> with the <strong>preliminary hazard analysis <\/strong>(PHA) method.<br \/>\nIn the case of the FMEA method, these are<strong> functions, failure type, failure effect, failure cause<\/strong> as well as the <strong>current and recommended measures.<\/strong><\/p>\n<p>With the risk analysis, you can build on your existing knowledge by copying or importing parts of the tree or a complete risk analysis, or by interactively using the knowledge database. Moreover, powerful tools are available including a content-dependent search-and-replace feature that \u2013 unlike Office applications \u2013 ensures that replacements are only implemented at the intended positions within your documentation.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6gj9dmf-fe90c65d065a44e7f36bc271816537b8\">\n.flex_column.av-6gj9dmf-fe90c65d065a44e7f36bc271816537b8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-6gj9dmf-fe90c65d065a44e7f36bc271816537b8 av_three_fifth  avia-builder-el-20  el_after_av_two_fifth  el_before_av_promobox  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-sub-av-6f483nb-1c943bde77428e13ee32db9cbc913a30\">\n.av-hotspot-image-container .av-image-hotspot.av-mxcn5z-ec095b9de381fa4c6e31e787bdc61797{\ntop:13.7%;\nleft:46%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-6b9b8s7-d11113191bce196b94089cdfe62d041f{\ntop:10%;\nleft:73.4%;\n}\n<\/style>\n<div  class='av-hotspot-image-container av-6f483nb-1c943bde77428e13ee32db9cbc913a30  avia-builder-el-21  avia-builder-el-no-sibling  av-hotspot-numbered av-mobile-fallback-active  av-non-fullwidth-hotspot-image'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class='av-hotspot-container'><div class='av-hotspot-container-inner-cell'><div class='av-hotspot-container-inner-wrap'><div class='av-image-hotspot av-mxcn5z-ec095b9de381fa4c6e31e787bdc61797 av-image-hotspot-1 ' data-avia-tooltip-position='bottom' data-avia-tooltip-alignment='right' data-avia-tooltip-class='av-tt-default-width av-tt-pos-below av-tt-align-right  av-mobile-fallback-active  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Structured procedure in a tree view&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>1<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-6b9b8s7-d11113191bce196b94089cdfe62d041f av-image-hotspot-2 ' data-avia-tooltip-position='bottom' data-avia-tooltip-alignment='right' data-avia-tooltip-class='av-tt-default-width av-tt-pos-below av-tt-align-right  av-mobile-fallback-active  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Description and categorisation of hazards&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>2<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-3726 avia-img-lazy-loading-not-3726 avia_image' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA.png\" alt='' title='Riskanalysis_PHA'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Riskanalysis_PHA-450x281.png 450w\" sizes=\"(max-width: 1680px) 100vw, 1680px\" \/><\/div><\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-1 '><div class=\"av-hotspot-fallback-tooltip-count\">1<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nStructured procedure in a tree view<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-2 '><div class=\"av-hotspot-fallback-tooltip-count\">2<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nDescription and categorisation of hazards<\/p>\n<\/div><\/div><\/div><\/div><div  class='av_promobox av-69cie47-40143420c044d2261b32e9363bbebfaa avia-button-yes  avia-builder-el-22  el_after_av_three_fifth  avia-builder-el-last '><div class='avia-promocontent'><p>\nWould you like to see the advantages of BAYOOSOFT Risk Manager for yourself? Download your free 30-day trial version today.<\/p>\n<\/div><div  class='avia-button-wrap av-69cie47-6c6cfb761433c03aef2395b03d714188-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-69cie47-6c6cfb761433c03aef2395b03d714188 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Request trial version now\"><span class='avia_iconbox_title' >Request trial version now<\/span><\/a><\/div><\/div><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-68rwsl3-e2d0f5a5af928ea6bf75560bf696676b\">\n.av-layout-tab.av-68rwsl3-e2d0f5a5af928ea6bf75560bf696676b{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-2' class='av-layout-tab av-68rwsl3-e2d0f5a5af928ea6bf75560bf696676b av-animation-delay-container  avia-builder-el-23  el_after_av_tab_sub_section  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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Presentation of the distribution of risk after evaluation' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3728 avia-img-lazy-loading-not-3728\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1030x644.png\" title='2-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3.png 1680w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Presentation of the distribution of risk after evaluation<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1030x644.png\" 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srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-3.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-1' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1030x644.png' class='lightbox ' data-onclick='2' title='Decision on the implementation of measures'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3730 avia-img-lazy-loading-not-3730\"  data-avia-tooltip='Decision on the implementation of measures' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-845x684.png\" width=\"845\" height=\"684\"  title='4' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3730 avia-img-lazy-loading-3730\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1030x644.png\" title='4' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/4-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-63qz5uf-cf0630b7b14324c33d2bec1997e19370\">\n.flex_column.av-63qz5uf-cf0630b7b14324c33d2bec1997e19370{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-63qz5uf-cf0630b7b14324c33d2bec1997e19370 av_one_half  avia-builder-el-26  el_after_av_one_half  el_before_av_promobox  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-615kgqv-e64614e2eb2f1773c657382330451500\">\n#top .hr.hr-invisible.av-615kgqv-e64614e2eb2f1773c657382330451500{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-615kgqv-e64614e2eb2f1773c657382330451500 hr-invisible  avia-builder-el-27  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-60ajzuf-e7227429ab9f7f4012586770042783d2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Depending on the chosen method (<a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#failure-mode-and-effect-analysis\">FMEA<\/a> or <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#preliminary-hazard-analysis\">PHA<\/a>), the risks are assessed at the level of causes or based on the combination of failure type, failure effect and failure cause. The risk graph or FMEA diagram is updated even while entering the assessment. This means you can instantly see the current assessment status for the respective measure through to the complete component, product or process.<br \/>\nBAYOOSOFT Risk Manager automatically calculates the efficiency of the risk-reducing measures you take and summarizes them in a clear list of results. This way, you can see at a glance which measures would reduce multiple risks at once and which measures reduce risks that lie outside the acceptable range, for example. The user selects the measures with the click of the mouse, which starts the process of measure management.<\/p>\n<\/div><\/section><\/p><\/div><div  class='av_promobox av-5xqm0w7-13d6f72c19fafb0c7e9dd43156f1ac53 avia-button-yes  avia-builder-el-29  el_after_av_one_half  avia-builder-el-last '><div class='avia-promocontent'><p>\nWould you like to see the advantages of BAYOOSOFT Risk Manager for yourself? Download your free 30-day trial version today.<\/p>\n<\/div><div  class='avia-button-wrap av-5xqm0w7-bd169bdee747ea643f5d7e3eadfa2d7b-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-5xqm0w7-bd169bdee747ea643f5d7e3eadfa2d7b av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Request trial version now\"><span class='avia_iconbox_title' >Request trial version now<\/span><\/a><\/div><\/div><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5w2j68n-dc6168c46d935a56c8ec7f5adebd30df\">\n.av-layout-tab.av-5w2j68n-dc6168c46d935a56c8ec7f5adebd30df{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-3' class='av-layout-tab av-5w2j68n-dc6168c46d935a56c8ec7f5adebd30df av-animation-delay-container  avia-builder-el-30  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"3\" data-tab-section-id=\"risk-governance\"><div class=\"av-layout-tab-inner\"><div class=\"container\"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5uuz3mf-ecbb7279b345c345ef8dab5f515e1a8b\">\n.flex_column.av-5uuz3mf-ecbb7279b345c345ef8dab5f515e1a8b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5uuz3mf-ecbb7279b345c345ef8dab5f515e1a8b av_one_half  avia-builder-el-31  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kycp9z-58a0edf9ed5618fb6e354d52530610c5 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>A <strong>key part of the technical documentation is the process of measure management.\u00a0<\/strong>BAYOOSOFT Risk Manager automatically calculates the <strong>efficiency<\/strong> of the risk-reducing measures taken and summarizes them in a clear list of results. This way, you can see at a glance which <strong>measures<\/strong> reduce multiple risks at once and which measures reduce risks that lie outside the acceptable range, for example. For each selected measure, you can:<\/p>\n<ul>\n<li>Define responsibilities (implementation and monitoring controllers)<\/li>\n<li>Compose implementation teams<\/li>\n<li>Add schedules and cost plans<\/li>\n<li>Define individual clearance criteria (e.g. process for proving effectiveness, process for verification and validation, acceptance limits)<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5r6exs7-6c7c603df27ec4d9e0eab34397a6114b\">\n.flex_column.av-5r6exs7-6c7c603df27ec4d9e0eab34397a6114b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5r6exs7-6c7c603df27ec4d9e0eab34397a6114b av_one_half  avia-builder-el-33  el_after_av_one_half  el_before_av_textblock  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5q1sbgn-cd787721dbe0f271cfcdf1c7586b29d4\">\n#top .avia-gallery.av-5q1sbgn-cd787721dbe0f271cfcdf1c7586b29d4 .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-5q1sbgn-cd787721dbe0f271cfcdf1c7586b29d4 avia_animate_when_visible  avia-builder-el-34  avia-builder-el-no-sibling  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-2'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-300x180.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-768x462.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1536x924.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1500x902.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-705x424.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-450x271.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1.png 1676w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Monitor and document the status of task implementation' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-4047 avia-img-lazy-loading-not-4047\"  width=\"1030\" height=\"619\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png\" title='1-1' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-300x180.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-768x462.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1536x924.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1500x902.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-705x424.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-450x271.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1.png 1676w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Monitor and document the status of task implementation<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-300x180.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-768x462.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1536x924.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1500x902.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-705x424.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-450x271.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1.png 1676w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-2' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png' class='first_thumb lightbox ' data-onclick='1' title='Monitor and document the status of task implementation'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-4047 avia-img-lazy-loading-not-4047\"  data-avia-tooltip='Monitor and document the status of task implementation' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-845x684.png\" width=\"845\" height=\"684\"  title='1-1' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-4047 avia-img-lazy-loading-4047\"  width=\"1030\" height=\"619\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png\" title='1-1' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1030x619.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-300x180.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-768x462.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1536x924.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-1500x902.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-705x424.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1-450x271.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/1-1.png 1676w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1030x641.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1500x934.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-2' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1030x641.png' class='lightbox ' data-onclick='2' title='Overview of the current action processing in the controlling overview'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3734 avia-img-lazy-loading-not-3734\"  data-avia-tooltip='Overview of the current action processing in the controlling overview' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-845x684.png\" width=\"845\" height=\"684\"  title='3' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3734 avia-img-lazy-loading-3734\"  width=\"1030\" height=\"641\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1030x641.png\" title='3' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-1500x934.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/div><section  class='av_textblock_section av-kecr2f-6837a3b602919f7f6b80837ffd97ddef '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>A<strong> controlling overview<\/strong> provides a summary of the current progress for all measures adopted.<br \/>\nWhen reassessing the risks, BAYOOSOFT Risk Manager checks whether risks were reduced without corresponding risk-reducing measures being implemented, and indicates this potential error to the user. If new hazards arise from the measures implemented, corresponding relationships can be established.<\/p>\n<p>The process is completed consistently by allowing new requirements to be generated from adopted measures at the press of a button.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5mdlg0n-a22beb67367911e176232d177a6352a7\">\n.av-layout-tab.av-5mdlg0n-a22beb67367911e176232d177a6352a7{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-4' class='av-layout-tab av-5mdlg0n-a22beb67367911e176232d177a6352a7 av-animation-delay-container  avia-builder-el-36  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"4\" data-tab-section-id=\"residual-risk-evaluation\"><div class=\"av-layout-tab-inner\"><div class=\"container\"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5koz37b-70e55e1e2a36babefc7bba365301a11a\">\n.flex_column.av-5koz37b-70e55e1e2a36babefc7bba365301a11a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5koz37b-70e55e1e2a36babefc7bba365301a11a av_three_fifth  avia-builder-el-37  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5imimaf-dfcdecb37ad7dc0772bc6ef98b160f42\">\n.avia-image-container.av-5imimaf-dfcdecb37ad7dc0772bc6ef98b160f42 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-5imimaf-dfcdecb37ad7dc0772bc6ef98b160f42 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-5imimaf-dfcdecb37ad7dc0772bc6ef98b160f42 av-styling- avia-align-center  avia-builder-el-38  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-3736 avia-img-lazy-loading-not-3736 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1.png\" alt='' title='2-3'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-3-1-450x281.png 450w\" sizes=\"(max-width: 1680px) 100vw, 1680px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5iaddjr-13061629e0f4d2bec21fb597fd183f1e\">\n.flex_column.av-5iaddjr-13061629e0f4d2bec21fb597fd183f1e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5iaddjr-13061629e0f4d2bec21fb597fd183f1e av_two_fifth  avia-builder-el-39  el_after_av_three_fifth  el_before_av_promobox  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5ggnjsn-15fce573f97ff2bc936040a12e171258\">\n#top .hr.hr-invisible.av-5ggnjsn-15fce573f97ff2bc936040a12e171258{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-5ggnjsn-15fce573f97ff2bc936040a12e171258 hr-invisible  avia-builder-el-40  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-5f1rufr-4a04fc2a04e47b2ffa39e11b3b8582c7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Risks are reassessed as part of a <strong>re-evaluation<\/strong> following implementation of the measures. The user can see in a risk graph which risks remain in which areas and can directly read out the effectiveness of risk reduction based on the <strong>before\/after overview<\/strong>. Interactive features guide the user directly to the points that do not meet the desired acceptance criteria and supports the user with the help of the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#self-learning-knowledge-database\">self-learning knowledge database<\/a> with suggestions that may lead to further risk reduction. Automatic checks support the user by assessing and reassessing all risks and helps avoid evaluation errors.<\/p>\n<\/div><\/section><\/p><\/div><div  class='av_promobox av-5dgbik7-20dcb77032a2c7582289fe15f1f354ff avia-button-yes  avia-builder-el-42  el_after_av_two_fifth  avia-builder-el-last '><div class='avia-promocontent'><p>\nWould you like to see the advantages of BAYOOSOFT Risk Manager for yourself? Download your free 30-day trial version today.<\/p>\n<\/div><div  class='avia-button-wrap av-5dgbik7-def0a4099991d3541e2273200a9d8baa-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-5dgbik7-def0a4099991d3541e2273200a9d8baa av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Request trial version now\"><span class='avia_iconbox_title' >Request trial version now<\/span><\/a><\/div><\/div><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5bgk50n-fb39bb05087ac93cac481251dd7f86ed\">\n.av-layout-tab.av-5bgk50n-fb39bb05087ac93cac481251dd7f86ed{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-5' class='av-layout-tab av-5bgk50n-fb39bb05087ac93cac481251dd7f86ed av-animation-delay-container  avia-builder-el-43  el_after_av_tab_sub_section  avia-builder-el-last  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"5\" data-tab-section-id=\"risk-monitoring\"><div class=\"av-layout-tab-inner\"><div class=\"container\"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-58pogvb-250ae3680e60c5efb8ba04b97651555d\">\n.flex_column.av-58pogvb-250ae3680e60c5efb8ba04b97651555d{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-58pogvb-250ae3680e60c5efb8ba04b97651555d av_two_fifth  avia-builder-el-44  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5723u2v-7ded074ddf718e09ee5ad0b7ad2d47aa\">\n#top .hr.hr-invisible.av-5723u2v-7ded074ddf718e09ee5ad0b7ad2d47aa{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-5723u2v-7ded074ddf718e09ee5ad0b7ad2d47aa hr-invisible  avia-builder-el-45  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-56gksuf-0865426e266d871341630c9e726eeb4a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a manufacturer of medical devices, you are subject to a vigilance system according to European medical devices law, which encompasses all levels of <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#post-market-surveillance\">market monitoring<\/a> for the medical devices you bring into circulation. This includes monitoring and assessing all incidents and corresponding hazard prevention, such as recalls. BAYOOSOFT Risk Manager offers you a dedicated area for market monitoring, allowing you to document your observations. If during market monitoring you determine that a new risk assessment is necessary, this can likewise be documented. The integrated reminder system lets you add BAYOOSOFT Risk Manager reminders to Microsoft Outlook or Lotus Notes, supporting you in regular market monitoring for the given product.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5466epz-a3a5c87c423c2c7dbf260515a60e1572\">\n.flex_column.av-5466epz-a3a5c87c423c2c7dbf260515a60e1572{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5466epz-a3a5c87c423c2c7dbf260515a60e1572 av_three_fifth  avia-builder-el-47  el_after_av_two_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-52m1nt3-676c24e0561ca070ff82919f4ba0ab65\">\n#top .avia-gallery.av-52m1nt3-676c24e0561ca070ff82919f4ba0ab65 .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-52m1nt3-676c24e0561ca070ff82919f4ba0ab65 avia_animate_when_visible  avia-builder-el-48  avia-builder-el-no-sibling  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-3'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Documentation of market observation events' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3738 avia-img-lazy-loading-not-3738\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png\" title='1-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1.png 1680w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Documentation of market observation events<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-3' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png' class='first_thumb lightbox ' data-onclick='1' title='Documentation of market observation events'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3738 avia-img-lazy-loading-not-3738\"  data-avia-tooltip='Documentation of market observation events' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-845x684.png\" width=\"845\" height=\"684\"  title='1-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3738 avia-img-lazy-loading-3738\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png\" title='1-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-2-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-3' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1030x644.png' class='lightbox ' data-onclick='2' title='Setting reminders to carry out market monitoring'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3740 avia-img-lazy-loading-not-3740\"  data-avia-tooltip='Setting reminders to carry out market monitoring' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-845x684.png\" width=\"845\" height=\"684\"  title='2-4' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3740 avia-img-lazy-loading-3740\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1030x644.png\" title='2-4' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-4-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/div><\/p>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-514wq2f-a839733a01d4e4779a77a7176443fb78\">\n.avia-section.av-514wq2f-a839733a01d4e4779a77a7176443fb78{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_387381838.jpg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n.avia-section.av-514wq2f-a839733a01d4e4779a77a7176443fb78 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='usability-engineering-en62366-en60601-1-6'  class='avia-section av-514wq2f-a839733a01d4e4779a77a7176443fb78 alternate_color avia-section-default avia-no-shadow  avia-builder-el-49  el_after_av_tab_section  el_before_av_section  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4za7j5z-8d6c1be513ae11a88bceaf39cc5d218b\">\n#top .av-special-heading.av-4za7j5z-8d6c1be513ae11a88bceaf39cc5d218b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-4za7j5z-8d6c1be513ae11a88bceaf39cc5d218b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-4za7j5z-8d6c1be513ae11a88bceaf39cc5d218b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-4za7j5z-8d6c1be513ae11a88bceaf39cc5d218b av-special-heading-h2 blockquote modern-quote  avia-builder-el-50  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Usability Engineering According to EN 62366 <span class='special_amp'>&amp;<\/span> IEC EN 60601-1-6<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-htomrb-f880fcd228c18ca13313dfa631c2e2b4 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The standard DIN EN 62366 <strong>obliges<\/strong> you as a manufacturer of medical devices to carry out a usability engineering process and document it in a usability engineering file. In doing so, not only do you fulfill the legal requirements, usability is also increasingly becoming a <strong>decisive sales factor<\/strong>. Implementing usability measures reduces the risk of operating errors for users, patients and third parties. At the same time, integrating representative users into the development process ensures a high level of acceptance for your product among your target group.<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wlat13-cd9032b4d3c55da52865a178a9bb56d2\">\n.flex_column.av-4wlat13-cd9032b4d3c55da52865a178a9bb56d2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4wlat13-cd9032b4d3c55da52865a178a9bb56d2 av_one_half  avia-builder-el-52  el_after_av_textblock  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4txwb1z-13e028524c3d7f24e845a286f0bfdf15\">\n#top .hr.hr-invisible.av-4txwb1z-13e028524c3d7f24e845a286f0bfdf15{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-4txwb1z-13e028524c3d7f24e845a286f0bfdf15 hr-invisible  avia-builder-el-53  el_before_av_gallery  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-haeeh3-97970add61a77cb58d37e9a6585f1dda\">\n#top .avia-gallery.av-haeeh3-97970add61a77cb58d37e9a6585f1dda .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-haeeh3-97970add61a77cb58d37e9a6585f1dda avia_animate_when_visible  avia-builder-el-54  el_after_av_hr  avia-builder-el-last  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-4'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Suitability for use test' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3742 avia-img-lazy-loading-not-3742\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png\" title='3-7' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1.png 1680w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Suitability for use test<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-4' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png' class='first_thumb lightbox ' data-onclick='1' title='Suitability for use test'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3742 avia-img-lazy-loading-not-3742\"  data-avia-tooltip='Suitability for use test' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-845x684.png\" width=\"845\" height=\"684\"  title='3-7' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3742 avia-img-lazy-loading-3742\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png\" title='3-7' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-7-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-4' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1030x644.png' class='lightbox ' data-onclick='2' title='Suitability for use test'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3744 avia-img-lazy-loading-not-3744\"  data-avia-tooltip='Suitability for use test' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-845x684.png\" width=\"845\" height=\"684\"  title='Summative Evaluation Plan' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3744 avia-img-lazy-loading-3744\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1030x644.png\" title='Summative Evaluation Plan' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-3.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4rsa0x3-e495a2a89801e572c480e4f3f754d32a\">\n.flex_column.av-4rsa0x3-e495a2a89801e572c480e4f3f754d32a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4rsa0x3-e495a2a89801e572c480e4f3f754d32a av_one_half  avia-builder-el-55  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-4pk781z-fc66419274e8e0f4bbba1be5ecbbc082 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>With the Usability Engineering extension module, BAYOOSOFT Risk Manager fully integrates the process into risk management according to ISO 14971 and guides you step by step to the usability engineering file based on a tried and tested macrostructure in accordance with DIN EN 62366 and IEC EN 60601-1-6.<\/p>\n<p>From intended<strong> usage conditions<\/strong> and medical indications, intended patient and user groups, usage scenarios and main usage functions and requirements through to validation plans and verification, such as with usability tests, focus groups, expert reviews or cognitive walkthroughs \u2013 BAYOOSOFT Risk Manager fully covers all aspects of IEC EN 60601-1-6 and EN 62366 and considerably accelerates your work processes.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='essential-requirements-mdr-ivdr'  class='avia-section av-4nr447b-f26748713f5fc6f4fae0fa5bbecfec5a alternate_color avia-section-default avia-no-shadow  avia-builder-el-57  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4mi4e0n-1915939db9ab97cbb352b9506bf26ba4\">\n#top .av-special-heading.av-4mi4e0n-1915939db9ab97cbb352b9506bf26ba4{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-4mi4e0n-1915939db9ab97cbb352b9506bf26ba4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-4mi4e0n-1915939db9ab97cbb352b9506bf26ba4 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-4mi4e0n-1915939db9ab97cbb352b9506bf26ba4 av-special-heading-h2 blockquote modern-quote  avia-builder-el-58  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Essential Requirements According to MDR 2017\/745 <span class='special_amp'>&amp;<\/span> IVDR 2017\/746<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-gie66f-3985274825b374a890e875b9db99f658\">\n.flex_column.av-gie66f-3985274825b374a890e875b9db99f658{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-gie66f-3985274825b374a890e875b9db99f658 av_one_half  avia-builder-el-59  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-4jkj5vr-5db9e74163425ba05a77e9e7d492e257 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>To obtain a <strong>CE marking<\/strong> for your medical device and hence approval for distribution in Europe, it\u2019s necessary to comply with essential requirements as well as a <strong>conformity assessment process<\/strong> prescribed for the respective medical device. In the case of in-vitro diagnostics, the essential requirements are stipulated in IVDR 2017\/746, and for other medical devices in MDR 2017\/745.<\/p>\n<p>The Essential Requirements module of BAYOOSOFT Risk Manager enables you to accelerate the review and evaluation of these essential requirements significantly. With the help of an <strong>interactive checklist<\/strong>, the requirements are filtered according to your medical device, meaning you only need to answer the relevant questions. At the same time, the module is connected to <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">risk management according to ISO 14971<\/a>, meaning <strong>no redundant risk assessments<\/strong> are required to answer it. This enables you to benefit from <strong>time savings<\/strong> of up to <strong>62% <\/strong>in reviewing the essential requirements, while you keep the technical documentation at the same assessment level consistently.<\/p>\n<p><a href=\"https:\/\/www.riskmanager.net\/en\/services\/test-now\">See for yourself as part of a 30-day trial<\/a> \n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4gtsmx3-15822b9b0caf22b679c2254cafb07c15\">\n.av_font_icon.av-4gtsmx3-15822b9b0caf22b679c2254cafb07c15{\ncolor:#23d3bc;\nborder-color:#23d3bc;\n}\n.av_font_icon.av-4gtsmx3-15822b9b0caf22b679c2254cafb07c15 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-4gtsmx3-15822b9b0caf22b679c2254cafb07c15 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><a href='https:\/\/www.riskmanager.net\/services\/jetzt-testen\/'   class='av-icon-char' aria-hidden='false' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' data-avia-icon-tooltip=\"&lt;br \/&gt;\nRequest TRIAL now&lt;br \/&gt;\n\"><\/a><\/span><\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4fh2y7b-a6fb5735e90b8f1eef85fa1b97076c69\">\n.flex_column.av-4fh2y7b-a6fb5735e90b8f1eef85fa1b97076c69{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4fh2y7b-a6fb5735e90b8f1eef85fa1b97076c69 av_one_half  avia-builder-el-62  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4edlhd3-f5dba93fa79984f0e8660abff53a2de9\">\n#top .hr.hr-invisible.av-4edlhd3-f5dba93fa79984f0e8660abff53a2de9{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-4edlhd3-f5dba93fa79984f0e8660abff53a2de9 hr-invisible  avia-builder-el-63  el_before_av_gallery  avia-builder-el-first '><span class='hr-inner 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href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Basic requirements according to MDR 2017\/745 and IVDR 2017\/746' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3752 avia-img-lazy-loading-not-3752\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png\" title='1-9' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-705x441.png 705w, 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srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3752 avia-img-lazy-loading-3752\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png\" title='1-9' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-9-2-1536x960.png 1536w, 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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1.png 1681w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-5' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-1030x641.png' class='lightbox ' data-onclick='2' title='Basic requirements according to MDR 2017\/745 and IVDR 2017\/746'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3748 avia-img-lazy-loading-not-3748\"  data-avia-tooltip='Basic requirements according to MDR 2017\/745 and IVDR 2017\/746' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-845x684.png\" width=\"845\" height=\"684\"  title='2-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3748 avia-img-lazy-loading-3748\"  width=\"1030\" height=\"641\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-1030x641.png\" title='2-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-10-1-1536x956.png 1536w, 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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-5' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1030x644.png' class='lightbox ' data-onclick='3' title='Basic requirements according to MDR 2017\/745 and IVDR 2017\/746'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3750 avia-img-lazy-loading-not-3750\"  data-avia-tooltip='Basic requirements according to MDR 2017\/745 and IVDR 2017\/746' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-845x684.png\" width=\"845\" height=\"684\"  title='3-8' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3750 avia-img-lazy-loading-3750\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1030x644.png\" title='3-8' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-8-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='medical-electric-equipment-60601-1'  class='avia-section av-4b0pezb-8dc8d524b6db66efe0377cd051720ccb main_color avia-section-default avia-no-shadow  avia-builder-el-65  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-fck1hz-a6c393467ff44d8a85d8209d101d1dd8\">\n#top .av-special-heading.av-fck1hz-a6c393467ff44d8a85d8209d101d1dd8{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-fck1hz-a6c393467ff44d8a85d8209d101d1dd8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-fck1hz-a6c393467ff44d8a85d8209d101d1dd8 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-fck1hz-a6c393467ff44d8a85d8209d101d1dd8 av-special-heading-h2 blockquote modern-quote  avia-builder-el-66  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Conformity Report for Medical Electrical Equipment<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f53wpz-6323f84e2016cbfdca452233ee485fc2\">\n.flex_column.av-f53wpz-6323f84e2016cbfdca452233ee485fc2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-f53wpz-6323f84e2016cbfdca452233ee485fc2 av_one_half  avia-builder-el-67  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-45beig7-37518d3e6491098af047b594005d3083\">\n#top .hr.hr-invisible.av-45beig7-37518d3e6491098af047b594005d3083{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-45beig7-37518d3e6491098af047b594005d3083 hr-invisible  avia-builder-el-68  el_before_av_gallery  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-43s3zhz-b65280331b4f559868d3be8e60e5669e\">\n#top .avia-gallery.av-43s3zhz-b65280331b4f559868d3be8e60e5669e .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-43s3zhz-b65280331b4f559868d3be8e60e5669e avia_animate_when_visible  avia-builder-el-69  el_after_av_hr  avia-builder-el-last  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-6'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1.png 1681w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3758 avia-img-lazy-loading-not-3758\"  width=\"1030\" height=\"641\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png\" title='2-11' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1.png 1681w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-11-1-450x280.png 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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-6' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png' class='lightbox ' data-onclick='3' title='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3754 avia-img-lazy-loading-not-3754\"  data-avia-tooltip='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-845x684.png\" width=\"845\" height=\"684\"  title='1-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3754 avia-img-lazy-loading-3754\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png\" title='1-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-421fonb-d7db50d255927c5f99421e2b9fc03564\">\n.flex_column.av-421fonb-d7db50d255927c5f99421e2b9fc03564{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-421fonb-d7db50d255927c5f99421e2b9fc03564 av_one_half  avia-builder-el-70  el_after_av_one_half  avia-builder-el-last  flex_column_div 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decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6980 avia-img-lazy-loading-not-6980\"   src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-845x684.jpg\" width=\"845\" height=\"684\"  title='Machinery Directive' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-845x684.jpg 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-495x400.jpg 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6980 avia-img-lazy-loading-6980\"  width=\"1030\" height=\"687\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-1030x687.jpg\" title='Machinery Directive' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-2048x1366.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_727711573-705x470.jpg 705w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1030x688.jpg\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1030x688.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-768x513.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1536x1025.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-2048x1367.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1500x1001.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-705x471.jpg 705w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-7' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1030x688.jpg' class='lightbox ' data-onclick='2' title='Machinery Directive'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6991 avia-img-lazy-loading-not-6991\"   src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-845x684.jpg\" width=\"845\" height=\"684\"  title='Machinery Directive' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-845x684.jpg 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-495x400.jpg 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6991 avia-img-lazy-loading-6991\"  width=\"1030\" height=\"688\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1030x688.jpg\" title='Machinery Directive' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1030x688.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-768x513.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1536x1025.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-2048x1367.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-1500x1001.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-705x471.jpg 705w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-421fonb-d7db50d255927c5f99421e2b9fc03564\">\n.flex_column.av-421fonb-d7db50d255927c5f99421e2b9fc03564{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-421fonb-d7db50d255927c5f99421e2b9fc03564 av_one_half  avia-builder-el-77  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-40upm9z-4a3cee10d0ca941f694e4927fa89aa86 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The<strong> Machinery Directive 2006\/42\/EC<\/strong> and the<strong> revised version 95\/16\/EC<\/strong> define a uniform level of protection to prevent accidents in the European Economic Area during the use of machinery. In addition, fundamental standards in health protection are defined.<\/p>\n<p>With the extension module for the Machinery Directive, the BAYOOSOFT Risk Manager supports you in taking all requirements into account:<\/p>\n<ul>\n<li>With the help of the checklist-based documentation, you can easily and quickly record all requirements for a uniform level of protection for accident prevention.<\/li>\n<li>Using filters, you receive dynamically generated checklists and thus an overview of the requirements to be fulfilled. The checklist is structured analogously to the structure of the standard.<\/li>\n<li>The extension module also enables the complete integration of the risk management process according to <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">ISO 14971<\/a>, including the transfer of existing data from the analyses and assessments.<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3yjq09j-3e474597b3dba5bdd4d71f094deb1354\">\n.avia-section.av-3yjq09j-3e474597b3dba5bdd4d71f094deb1354{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_142302319.jpg);\nbackground-position:100% 0%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id='requirements-engineering-traceability'  class='avia-section av-3yjq09j-3e474597b3dba5bdd4d71f094deb1354 alternate_color avia-section-default avia-no-shadow  avia-builder-el-79  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-fixed container_wrap fullsize'  data-section-bg-repeat='stretch'><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3x01z7b-7ee3b36166e3c68a653a668566ea762e\">\n.flex_column.av-3x01z7b-7ee3b36166e3c68a653a668566ea762e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3x01z7b-7ee3b36166e3c68a653a668566ea762e av_one_half  avia-builder-el-80  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca\">\n#top .av-special-heading.av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca{\npadding-bottom:10px;\ncolor:#23d3bc;\n}\nbody .av-special-heading.av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca .special-heading-inner-border{\nborder-color:#23d3bc;\n}\n.av-special-heading.av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-3vciezr-dc9784d9bb5db2a03874c9ca693da7ca av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-81  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >REQUIREMENTS ENGINEERING<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-dsq83r-89793fae013e3ea7c5ae38a1625db09d '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Requirements engineering is a key component in the efficient and low-error development of complex medical device systems and is particularly important for complex product and system concepts as well as shared development. Besides defining and implementing processes, this also covers the <strong>traceability<\/strong> of all specific requirements throughout the entire product lifecycle, as well as <strong>verifying\/validating<\/strong> the requirements accordingly.<\/p>\n<p>BAYOOSOFT Risk Manager fully integrates requirements engineering into the <strong>regulatory process<\/strong> that medical device manufacturers need to observe. New requirements can therefore automatically be derived from measures. What\u2019s more, there is a direct connection between requirements <strong>(traceability across various documents)<\/strong>, with resulting functions<strong> and validation and verification. Requirements relevant to <\/strong><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#usability-engineering-en62366-en60601-1-6\">usability<\/a><strong> are integrated into the usability engineering process, completely eliminating redundant data capture.<\/strong><\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3sblt0n-71431f09d05a9e65c5d8c5ab060b6b34\">\n.flex_column.av-3sblt0n-71431f09d05a9e65c5d8c5ab060b6b34{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3sblt0n-71431f09d05a9e65c5d8c5ab060b6b34 av_one_half  avia-builder-el-83  el_after_av_one_half  el_before_av_textblock  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3rfuz1j-82ac652c91d21f9f176131b1b616f175\">\n#top .hr.hr-invisible.av-3rfuz1j-82ac652c91d21f9f176131b1b616f175{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-3rfuz1j-82ac652c91d21f9f176131b1b616f175 hr-invisible  avia-builder-el-84  el_before_av_gallery  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3pskmmf-446083534649f4b1ad4b7ee8558f87d3\">\n#top .avia-gallery.av-3pskmmf-446083534649f4b1ad4b7ee8558f87d3 .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-3pskmmf-446083534649f4b1ad4b7ee8558f87d3 avia_animate_when_visible  avia-builder-el-85  el_after_av_hr  avia-builder-el-last  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-8'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1.png 1681w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Recording the requirements' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3762 avia-img-lazy-loading-not-3762\"  width=\"1030\" height=\"641\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png\" title='3-9' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1.png 1681w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Recording the requirements<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1.png 1681w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-8' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png' class='first_thumb lightbox ' data-onclick='1' title='Recording the requirements'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3762 avia-img-lazy-loading-not-3762\"  data-avia-tooltip='Recording the requirements' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-845x684.png\" width=\"845\" height=\"684\"  title='3-9' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3762 avia-img-lazy-loading-3762\"  width=\"1030\" height=\"641\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png\" title='3-9' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1030x641.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-300x187.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-768x478.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1536x956.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-1500x933.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-705x439.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1-450x280.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/3-9-1.png 1681w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-8' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1030x644.png' class='lightbox ' data-onclick='2' title='Recording the requirements'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3760 avia-img-lazy-loading-not-3760\"  data-avia-tooltip='Recording the requirements' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-845x684.png\" width=\"845\" height=\"684\"  title='1-11' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3760 avia-img-lazy-loading-3760\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1030x644.png\" title='1-11' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-11-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/p><\/div><section  class='av_textblock_section av-3namo9j-3c6259571934665a4e564b1fae3abbf9 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><a href=\"https:\/\/www.riskmanager.net\/en\/services\/test-now\">See for yourself as part of a 30-day trial <\/a>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3ldpypj-6f0ff6e38c15d3c8db6d12017c9c74e3\">\n.av_font_icon.av-3ldpypj-6f0ff6e38c15d3c8db6d12017c9c74e3{\ncolor:#23d3bc;\nborder-color:#23d3bc;\n}\n.av_font_icon.av-3ldpypj-6f0ff6e38c15d3c8db6d12017c9c74e3 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-3ldpypj-6f0ff6e38c15d3c8db6d12017c9c74e3 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><a href='https:\/\/www.riskmanager.net\/services\/jetzt-testen\/'   class='av-icon-char' aria-hidden='false' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' data-avia-icon-tooltip=\"&lt;br \/&gt;\nRequest a TRIAL now&lt;br \/&gt;\n\"><\/a><\/span><\/p>\n<\/div><\/section>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='clinical-evaluation'  class='avia-section av-3kkj2x3-0d0cd21c5f61d152ef29d4819d6b1074 main_color avia-section-default avia-no-shadow  avia-builder-el-88  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3hwf2qf-720c855973dba5bbcf1995708df75d03\">\n#top .av-special-heading.av-3hwf2qf-720c855973dba5bbcf1995708df75d03{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-3hwf2qf-720c855973dba5bbcf1995708df75d03 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-3hwf2qf-720c855973dba5bbcf1995708df75d03 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-3hwf2qf-720c855973dba5bbcf1995708df75d03 av-special-heading-h2 blockquote modern-quote  avia-builder-el-89  el_before_av_two_fifth  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Clinical Evaluation<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div class='flex_column_table av-3hj6to7-31d61723e649cca4db405e02d02c529c sc-av_two_fifth av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3hj6to7-31d61723e649cca4db405e02d02c529c\">\n.flex_column.av-3hj6to7-31d61723e649cca4db405e02d02c529c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3hj6to7-31d61723e649cca4db405e02d02c529c av_two_fifth  avia-builder-el-90  el_after_av_heading  el_before_av_three_fifth  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><section  class='av_textblock_section av-3fc0td3-fc4e25f8e5db8bd0937ddd3582656664 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The medical device regulation <strong>MDR 2017\/745<\/strong> obliges you as a manufacturer of medical devices to perform a clinical evaluation throughout the <strong>entire lifecycle<\/strong> of a medical device. In addition to the systematic collection and analysis of pertinent clinical data from various sources, this encompasses a clinical follow-up of the medical device on the market.<\/p>\n<p>The extension module of BAYOOSOFT Risk Manager enables you to generate clinical evaluations compliant with MDR and <strong>MEDDEV 2.7.1 rev4<\/strong>. They contain all relevant information for complying with the regulatory requirements. At the same time, complete coverage of the process as well as intuitive user guidance enables you to identify and check relevant data straight away.<\/p>\n<\/div><\/section><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3e007fb-a8e49f505fea811f45492a71a6815fec\">\n.flex_column.av-3e007fb-a8e49f505fea811f45492a71a6815fec{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3e007fb-a8e49f505fea811f45492a71a6815fec av_three_fifth  avia-builder-el-92  el_after_av_two_fifth  el_before_av_promobox  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-sub-av-3cmifwn-9e672d91e2ae67148dca692e6c4af862\">\n.av-hotspot-image-container .av-image-hotspot.av-3b0w3zb-e653269d93c159d191e5158e5bb6a924{\ntop:21.2%;\nleft:36.3%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-37xxzef-ecdaebe15e0bd4a14806c147cde51804{\ntop:79.4%;\nleft:29.9%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-bkf2bb-d4ab758d138a0ec89f90143ea46b346d{\ntop:8.1%;\nleft:89.1%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-35gcgkn-565de8c4c594c8fd8ee222765818b48f{\ntop:25.5%;\nleft:85.1%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-338jinb-bbad38f7fac335294f999163e16c8a46{\ntop:89.9%;\nleft:77.5%;\n}\n<\/style>\n<div  class='av-hotspot-image-container av-3cmifwn-9e672d91e2ae67148dca692e6c4af862  avia-builder-el-93  avia-builder-el-no-sibling  av-hotspot-numbered av-permanent-tooltip avia_animated_image avia_animate_when_almost_visible fade-in av-mobile-fallback-active  av-non-fullwidth-hotspot-image'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class='av-hotspot-container'><div class='av-hotspot-container-inner-cell'><div class='av-hotspot-container-inner-wrap'><div class='av-image-hotspot av-3b0w3zb-e653269d93c159d191e5158e5bb6a924 av-image-hotspot-1 av-permanent-tooltip' data-avia-tooltip-position='top' data-avia-tooltip-alignment='left' data-avia-tooltip-class='av-tt-default-width av-tt-pos-above av-tt-align-left  av-mobile-fallback-active  av-permanent-tooltip-single  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Listing of all search results with current processing status&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>1<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-37xxzef-ecdaebe15e0bd4a14806c147cde51804 av-image-hotspot-2 av-permanent-tooltip' data-avia-tooltip-position='top' data-avia-tooltip-alignment='left' data-avia-tooltip-class='av-tt-default-width av-tt-pos-above av-tt-align-left  av-mobile-fallback-active  av-permanent-tooltip-single  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Integration of the Abstract&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>2<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-bkf2bb-d4ab758d138a0ec89f90143ea46b346d av-image-hotspot-3 av-permanent-tooltip' data-avia-tooltip-position='bottom' data-avia-tooltip-alignment='left' data-avia-tooltip-class='av-tt-default-width av-tt-pos-below av-tt-align-left  av-mobile-fallback-active  av-permanent-tooltip-single  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;First assessment based on title and abstract&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>3<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-35gcgkn-565de8c4c594c8fd8ee222765818b48f av-image-hotspot-4 av-permanent-tooltip' data-avia-tooltip-position='left' data-avia-tooltip-alignment='bottom' data-avia-tooltip-class='av-tt-default-width av-tt-pos-left av-tt-align-bottom  av-mobile-fallback-active  av-permanent-tooltip-single  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;More detailed evaluation based on the full text&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>4<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-338jinb-bbad38f7fac335294f999163e16c8a46 av-image-hotspot-5 av-permanent-tooltip' data-avia-tooltip-position='top' data-avia-tooltip-alignment='left' data-avia-tooltip-class='av-tt-default-width av-tt-pos-above av-tt-align-left  av-mobile-fallback-active  av-permanent-tooltip-single  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Conclusion of the evaluation&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>5<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4053 avia-img-lazy-loading-not-4053 avia_image' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung.png\" alt='' title='Recherche Klinische Bewertung'  height=\"1008\" width=\"1672\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung.png 1672w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-300x181.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-1030x621.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-768x463.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-1536x926.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-1500x904.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-705x425.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Recherche-Klinische-Bewertung-450x271.png 450w\" sizes=\"(max-width: 1672px) 100vw, 1672px\" \/><\/div><\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-1 av-permanent-tooltip'><div class=\"av-hotspot-fallback-tooltip-count\">1<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nListing of all search results with current processing status<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-2 av-permanent-tooltip'><div class=\"av-hotspot-fallback-tooltip-count\">2<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nIntegration of the Abstract<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-3 av-permanent-tooltip'><div class=\"av-hotspot-fallback-tooltip-count\">3<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nFirst assessment based on title and abstract<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-4 av-permanent-tooltip'><div class=\"av-hotspot-fallback-tooltip-count\">4<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nMore detailed evaluation based on the full text<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-5 av-permanent-tooltip'><div class=\"av-hotspot-fallback-tooltip-count\">5<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nConclusion of the evaluation<\/p>\n<\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-31zui9j-92b296c4f1ecfd87155827975af4a686 avia-button-yes  avia-builder-el-94  el_after_av_three_fifth  avia-builder-el-last '><div class='avia-promocontent'><p>Find out more about the clinical evaluation as part of a product presentation.<\/p>\n<\/div><div  class='avia-button-wrap av-31zui9j-fa65c4f85ad7f08f7e472b1c4a445324-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-31zui9j-fa65c4f85ad7f08f7e472b1c4a445324 av-link-btn avia-icon_select-no avia-size-medium avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Arrange a consultation now\"><span class='avia_iconbox_title' >Arrange a consultation now<\/span><\/a><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='software-lifecycle-process-iec62304'  class='avia-section av-as0wh3-c8a13c9c6715b221cd9d588dd2088903 alternate_color avia-section-default avia-no-shadow  avia-builder-el-95  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2zd9ddz-7ce81413420a14904af5ef9776a15163\">\n#top .av-special-heading.av-2zd9ddz-7ce81413420a14904af5ef9776a15163{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-2zd9ddz-7ce81413420a14904af5ef9776a15163 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-2zd9ddz-7ce81413420a14904af5ef9776a15163 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-2zd9ddz-7ce81413420a14904af5ef9776a15163 av-special-heading-h2 blockquote modern-quote  avia-builder-el-96  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Software Lifecycle Process<\/h2><div class='av-subheading av-subheading_below'><p>Requirements of IEC 62304 on software lifecycle processes<\/p>\n<\/div><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2wxh08n-c483e765349059e8ba872d790d7918df\">\n#top .hr.hr-invisible.av-2wxh08n-c483e765349059e8ba872d790d7918df{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-2wxh08n-c483e765349059e8ba872d790d7918df hr-invisible  avia-builder-el-97  el_after_av_heading  el_before_av_one_half '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div class='flex_column_table av-2vcmjef-55a32a3eb03b6794ac2265a4b42aea7a sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2vcmjef-55a32a3eb03b6794ac2265a4b42aea7a\">\n.flex_column.av-2vcmjef-55a32a3eb03b6794ac2265a4b42aea7a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2vcmjef-55a32a3eb03b6794ac2265a4b42aea7a av_one_half  avia-builder-el-98  el_after_av_hr  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-sub-av-2ubhion-87c7095eedb6cf248d0e75cd988b9abb\">\n.av-hotspot-image-container .av-image-hotspot.av-2s510l3-b9c1171f0e1106ceed71f0a44be45a83{\ntop:15.6%;\nleft:29.6%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-2r4lad3-7a740bf837ab9fdc22a9c19a5fe6ccdb{\ntop:54.4%;\nleft:15.5%;\n}\n.av-hotspot-image-container .av-image-hotspot.av-2otdj53-bf0c3b586e4b273d223dca2f9fe5e405{\ntop:56.1%;\nleft:49.4%;\n}\n<\/style>\n<div  class='av-hotspot-image-container av-2ubhion-87c7095eedb6cf248d0e75cd988b9abb  avia-builder-el-99  avia-builder-el-no-sibling  av-hotspot-numbered avia_animated_image avia_animate_when_almost_visible fade-in av-mobile-fallback-active  av-non-fullwidth-hotspot-image'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class='av-hotspot-container'><div class='av-hotspot-container-inner-cell'><div class='av-hotspot-container-inner-wrap'><div class='av-image-hotspot av-2s510l3-b9c1171f0e1106ceed71f0a44be45a83 av-image-hotspot-1 ' data-avia-tooltip-position='right' data-avia-tooltip-alignment='bottom' data-avia-tooltip-class='av-tt-large-width av-tt-pos-right av-tt-align-bottom  av-mobile-fallback-active  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Clear requirements are legally necessary and at the same time essential for good products and efficient processes&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>1<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-2r4lad3-7a740bf837ab9fdc22a9c19a5fe6ccdb av-image-hotspot-2 ' data-avia-tooltip-position='right' data-avia-tooltip-alignment='bottom' data-avia-tooltip-class='av-tt-large-width av-tt-pos-right av-tt-align-bottom  av-mobile-fallback-active  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;IEC 62304 requires a risk analysis as an integral part of the development process:&lt;\/p&gt;\n&lt;ul&gt;\n&lt;li&gt;Software components must be considered in the hazardous situations&lt;\/li&gt;\n&lt;li&gt;Appropriate measures are to be implemented in the software&lt;\/li&gt;\n&lt;\/ul&gt;\n'><div class='av-image-hotspot_inner'>2<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><div class='av-image-hotspot av-2otdj53-bf0c3b586e4b273d223dca2f9fe5e405 av-image-hotspot-3 ' data-avia-tooltip-position='right' data-avia-tooltip-alignment='bottom' data-avia-tooltip-class='av-tt-large-width av-tt-pos-right av-tt-align-bottom  av-mobile-fallback-active  main_color av-tt-hotspot' data-avia-tooltip='&lt;p&gt;Proof of the conforming implementation of IEC 62304 can be provided by traceability.&lt;\/p&gt;\n'><div class='av-image-hotspot_inner'>3<\/div><div class='av-image-hotspot-pulse'><\/div><\/div><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4071 avia-img-lazy-loading-not-4071 avia_image' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN.png\" alt='' title='IEC620304_Traceability_v2 (EN)'  height=\"813\" width=\"1707\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN.png 1707w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-300x143.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-1030x491.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-768x366.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-1536x732.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-1500x714.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-705x336.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304_Traceability_v2-EN-450x214.png 450w\" sizes=\"(max-width: 1707px) 100vw, 1707px\" \/><\/div><\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-1 '><div class=\"av-hotspot-fallback-tooltip-count\">1<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nClear requirements are legally necessary and at the same time essential for good products and efficient processes<\/p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-2 '><div class=\"av-hotspot-fallback-tooltip-count\">2<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nIEC 62304 requires a risk analysis as an integral part of the development process:<\/p>\n<ul>\n<li>Software components must be considered in the hazardous situations<\/li>\n<li>Appropriate measures are to be implemented in the software<\/li>\n<\/ul>\n<p>\n<\/div><\/div><div class='av-hotspot-fallback-tooltip av-image-hotspot-3 '><div class=\"av-hotspot-fallback-tooltip-count\">3<div class=\"avia-arrow\"><\/div><\/div><div class=\"av-hotspot-fallback-tooltip-inner clearfix\"><p>\nProof of the conforming implementation of IEC 62304 can be provided by traceability.<\/p>\n<\/div><\/div><\/div><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2na1agn-892038335316235120ccb77e835bd889\">\n.flex_column.av-2na1agn-892038335316235120ccb77e835bd889{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2na1agn-892038335316235120ccb77e835bd889 av_one_half  avia-builder-el-100  el_after_av_one_half  el_before_av_textblock  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><section  class='av_textblock_section av-2m1cpif-3fe557af035c8664e6517d959ef8460f '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>IEC 62304 applies to the development and maintenance of <strong>medical device software<\/strong> if the software itself is a medical device or an embedded or integral component of a finished medical device. It stipulates that the medical device software must be developed and maintained <strong>within a risk management system.<\/strong> This means, for example, that software requirements must be considered as part of risk analysis. At the same time, it is important to ensure that effective measures are considered in the software requirements.<\/p>\n<p><strong>Traceability matrices<\/strong> can be used as proof that the medical device software has been developed in compliance with IEC 62304. These make sure that customer requirements are checked as part of suitable <strong>validation processes<\/strong> and that they are integrated into the software and <strong>verified<\/strong> against the requirements. Especially for large systems, this can be a challenging task.<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><section  class='av_textblock_section av-2jz6qon-9cf80051b69caef4816a50960d4cd6ff '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager offers a solution for preparing technical documentation in compliance with IEC 62304 for developing your medical device software. Here, the two extension modules <strong><a href=\"\/en\/modules-features\/modules\/#requirements-engineering-traceability\">Requirements Engineering<\/a><\/strong> and <strong><a href=\"\/en\/modules-features\/modules\/#rest-api\">REST API<\/a> <\/strong>are combined with risk management according to ISO 14971:<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2i6ts6v-939c68aafb92de35368a527af8c48ade\">\n.av_font_icon.av-2i6ts6v-939c68aafb92de35368a527af8c48ade{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-2i6ts6v-939c68aafb92de35368a527af8c48ade .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-2i6ts6v-939c68aafb92de35368a527af8c48ade avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p style=\"padding-left: 40px\">Seamless integration of requirements management into risk management enables you to replace redundant entries and manual copying with just a few clicks in the system. Connect requirements with functions in risk management as well as requirements at a further level (traceability) or quickly and easily create new requirements based on the effective measures.<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2g9as5z-99ff1f4e20ac9b373b03e7c2224bd96b\">\n.av_font_icon.av-2g9as5z-99ff1f4e20ac9b373b03e7c2224bd96b{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-2g9as5z-99ff1f4e20ac9b373b03e7c2224bd96b .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-2g9as5z-99ff1f4e20ac9b373b03e7c2224bd96b avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p style=\"padding-left: 40px\">Create test plans for validating and verifying the requirements and document the respective test runs. Test cases are linked directly with requirements, also allowing you to ensure permanent traceability here.<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2el903b-e207818a97f822c04a60c061903f7fe4\">\n.av_font_icon.av-2el903b-e207818a97f822c04a60c061903f7fe4{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-2el903b-e207818a97f822c04a60c061903f7fe4 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-2el903b-e207818a97f822c04a60c061903f7fe4 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p style=\"padding-left: 40px\">Ensure all requirements are linked with user stories in source code management, for example. The REST API opens up the further system environment for you in this connection. Integrate your source code management or ticket system for post-market surveillance \u2013 also enabling you to directly link with elements at other levels.<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2dc4cfr-4c0334318c9c478a63cc5b63bee7e08e\">\n.av_font_icon.av-2dc4cfr-4c0334318c9c478a63cc5b63bee7e08e{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-2dc4cfr-4c0334318c9c478a63cc5b63bee7e08e .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-2dc4cfr-4c0334318c9c478a63cc5b63bee7e08e avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p style=\"padding-left: 40px\">Finally, simply generate your traceability matrices at the press of a button based on the auditable and centrally stored, fine-grained and dynamically interconnected information. Moreover, the integrated version management of BAYOOSOFT Risk Manager enables you to \u201cclose\u201d certain version statuses, so that they can no longer be changed retroactively.<\/p>\n<\/div><\/section>\n<section  class='av_textblock_section av-2axo7ef-22583e38bb97d424a53b27335260a5c4 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Which systems should you link for IEC 62304-compliant software development?<\/strong><\/p>\n<p><a href=\"https:\/\/www.riskmanager.net\/en\/services\/contact\">We will be happy to explore your questions and topics with you as part of a call or individual webinar.\u00a0<\/a>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-29nvr9j-b48bfcdd6d19564537e8d926a3bfeeb3\">\n.av_font_icon.av-29nvr9j-b48bfcdd6d19564537e8d926a3bfeeb3{\ncolor:#23d3bc;\nborder-color:#23d3bc;\n}\n.av_font_icon.av-29nvr9j-b48bfcdd6d19564537e8d926a3bfeeb3 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-29nvr9j-b48bfcdd6d19564537e8d926a3bfeeb3 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><a href='https:\/\/www.riskmanager.net\/services\/jetzt-testen\/'   class='av-icon-char' aria-hidden='false' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' data-avia-icon-tooltip=\"&lt;br \/&gt;\nRequest a TRIAL now&lt;br \/&gt;\n\"><\/a><\/span><\/p>\n<\/div><\/section>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-288m4d3-bbbc1bbc6c8fd005b5f3febd35d752cd\">\n.avia-section.av-288m4d3-bbbc1bbc6c8fd005b5f3febd35d752cd{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_695865433-1500x1061.jpg);\nbackground-position:100% 50%;\nbackground-attachment:fixed;\n}\n.avia-section.av-288m4d3-bbbc1bbc6c8fd005b5f3febd35d752cd .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n<\/style>\n<div id='medical-it-networks-iec80001-1'  class='avia-section av-288m4d3-bbbc1bbc6c8fd005b5f3febd35d752cd main_color avia-section-default avia-no-shadow  avia-builder-el-109  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-26teewn-a3dab8777a8e4b095230b0c508b055fa\">\n#top .av-special-heading.av-26teewn-a3dab8777a8e4b095230b0c508b055fa{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-26teewn-a3dab8777a8e4b095230b0c508b055fa .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-26teewn-a3dab8777a8e4b095230b0c508b055fa .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-26teewn-a3dab8777a8e4b095230b0c508b055fa av-special-heading-h2 blockquote modern-quote  avia-builder-el-110  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Medical IT Network According to IEC 80001-1<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-kjsqvlex-de683e86caa1d737d57a7cd2c682071e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><a href=\"https:\/\/www.riskmanager.net\/en\/2020\/10\/05\/critis-crux-at-hospitals\/\" target=\"_blank\" rel=\"noopener\">IEC 80001-1 is directed at all IT network operators<\/a> who run at least one medical device in their network. In particular, this standard requires <strong>risk management throughout the entire lifecycle of the IT network<\/strong>, i.e. for as long as the medical device is part of the network.<\/p>\n<\/div><\/section>\n<div class='flex_column_table av-25ikvw7-779b09b511e00f734071cdbc48aca149 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-25ikvw7-779b09b511e00f734071cdbc48aca149\">\n.flex_column.av-25ikvw7-779b09b511e00f734071cdbc48aca149{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-25ikvw7-779b09b511e00f734071cdbc48aca149 av_one_half  avia-builder-el-112  el_after_av_textblock  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-22p3c47-8e4c4469627f43d6bc02ed91545282b6\">\n.avia-image-container.av-22p3c47-8e4c4469627f43d6bc02ed91545282b6 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-22p3c47-8e4c4469627f43d6bc02ed91545282b6 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-22p3c47-8e4c4469627f43d6bc02ed91545282b6 av-styling- avia-align-center  avia-builder-el-113  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-3836 avia-img-lazy-loading-not-3836 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul.png\" alt='' title='Med IT Network_Paul'  height=\"895\" width=\"1505\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul.png 1505w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-300x178.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-1030x613.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-768x457.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-1500x892.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-705x419.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Med-IT-Network_Paul-450x268.png 450w\" sizes=\"(max-width: 1505px) 100vw, 1505px\" \/><\/div><\/div><\/div><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7ciqqv-fd8b07a4006aa2ba4a1330e119541039\">\n.flex_column.av-7ciqqv-fd8b07a4006aa2ba4a1330e119541039{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-7ciqqv-fd8b07a4006aa2ba4a1330e119541039 av_one_half  avia-builder-el-114  el_after_av_one_half  el_before_av_promobox  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-1zo4kzb-248fb4ab577298e31b863ad11f9a6009 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager \u2013 the market-leading solution \u2013 offers you as an operator of such an IT network the ability to fulfill these regulatory requirements on risk management. Plan and document your IT networks with the software module: Risk Management According to IEC 80001-1. This allows you to take care of all <strong>requirements, manufacturers, network components<\/strong>, changes and monitoring in a central place. The structured environment of BAYOOSOFT Risk Manager is proven in practice with ISO 14971 and efficiently supports you in identifying risks at an early stage. Documentation encompasses the <strong>protective goals of safety, effectiveness as well as data and system security.<\/strong> The risk analysis and measure management of BAYOOSOFT Risk Manager help reduce potential hazards caused by interconnecting IT networks and medical devices. Moreover, the reliable and safe fulfillment of requirements set by the FDA and designated bodies accelerates approval processes and reduces the time to market.<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-1yqinvr-b908b7a731df598fa5552a4206934b0e avia-button-yes  avia-builder-el-116  el_after_av_one_half  avia-builder-el-last '><div class='avia-promocontent'><p>Would you like to find out more about risk management by IT network operators? Arrange a consultation for a product presentation today.<\/p>\n<\/div><div  class='avia-button-wrap av-1yqinvr-0cc7c8060214a0d980a98355569518ba-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-1yqinvr-0cc7c8060214a0d980a98355569518ba av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Arrange a consultation now\"><span class='avia_iconbox_title' >Arrange a consultation now<\/span><\/a><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='rest-api'  class='avia-section av-1wu1llj-6ae39904b127e15cfd510eb9d1084dc4 main_color avia-section-default avia-shadow  avia-builder-el-117  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1vkzq93-cda0b9c8ee2271d4f6c882788dcf350b\">\n#top .av-special-heading.av-1vkzq93-cda0b9c8ee2271d4f6c882788dcf350b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-1vkzq93-cda0b9c8ee2271d4f6c882788dcf350b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-1vkzq93-cda0b9c8ee2271d4f6c882788dcf350b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-1vkzq93-cda0b9c8ee2271d4f6c882788dcf350b av-special-heading-h2 blockquote modern-quote  avia-builder-el-118  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >REST API<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1tyxr1z-d8f3c1e1f80990e25a510be2d4a90573\">\n.flex_column.av-1tyxr1z-d8f3c1e1f80990e25a510be2d4a90573{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1tyxr1z-d8f3c1e1f80990e25a510be2d4a90573 av_one_half  avia-builder-el-119  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-1rvz29z-41da6a8677f65d7549924892059f942e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager offers a REST API as an extension for integration into existing infrastructure. If new insights emerge from ticket systems that need to be considered in market monitoring or if processes in your document management system require a new version of risk management files, these can be fully automatically transferred to BAYOOSOFT Risk Manager via the web interface and processed, for example<strong>. <\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1q7mztz-5f37aae5a3efb4c0e565c67e6027dc94\">\n#top .hr.hr-invisible.av-1q7mztz-5f37aae5a3efb4c0e565c67e6027dc94{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-1q7mztz-5f37aae5a3efb4c0e565c67e6027dc94 hr-invisible  avia-builder-el-121  el_after_av_textblock  el_before_av_iconlist '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-icon-list-container av-1ozfk5z-ed41d53c988406e6648c9b011bbb1113  avia-builder-el-122  el_after_av_hr  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-1ozfk5z-ed41d53c988406e6648c9b011bbb1113 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-1mj31pj-a816719a5bebc745cc2fcd47d7a2e255 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue822' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Seamless integration of risk management into your existing infrastructure\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Seamless integration of risk management into your existing infrastructure<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1lplvjr-637a5e523622ba932eedb3df218930c0 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue839' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Automated interaction with ERP applications, requirements engineering tools as well as ticket or intranet systems\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Automated interaction with ERP applications, requirements engineering tools as well as ticket or intranet systems<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1jwkhfb-ec03181f173c7416d54626b664d5ad77\">\n.flex_column.av-1jwkhfb-ec03181f173c7416d54626b664d5ad77{\nborder-width:2px;\nborder-color:#5f8789;\nborder-style:solid;\nborder-radius:1px 1px 1px 1px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1jwkhfb-ec03181f173c7416d54626b664d5ad77 av_one_half  avia-builder-el-123  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1hqt9tj-0d1b5efff5b32f5a113949bc4ae3887d\">\n.avia-image-container.av-1hqt9tj-0d1b5efff5b32f5a113949bc4ae3887d img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-1hqt9tj-0d1b5efff5b32f5a113949bc4ae3887d .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-1hqt9tj-0d1b5efff5b32f5a113949bc4ae3887d av-styling- avia-align-center  avia-builder-el-124  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2965 avia-img-lazy-loading-not-2965 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_135643841-845x684.jpg\" alt='' title='shutterstock_135643841'  height=\"684\" width=\"845\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_135643841-845x684.jpg 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_135643841-495x400.jpg 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1g7xj9z-0d67d6370797494599bd11ca5e68d0d0\">\n.avia-section.av-1g7xj9z-0d67d6370797494599bd11ca5e68d0d0{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Advanced-Reporting.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-1g7xj9z-0d67d6370797494599bd11ca5e68d0d0 .av-section-color-overlay{\nopacity:0.3;\nbackground-color:#000000;\n}\n<\/style>\n<div id='advanced-reporting'  class='avia-section av-1g7xj9z-0d67d6370797494599bd11ca5e68d0d0 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-125  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e\">\n#top .av-special-heading.av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-1eep2iv-0c3e3aade7f7a4c35fda4a2a8094301e av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-126  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Advanced Reporting<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1cf4rlz-53ccf824e36106f16a9137172e844fdb\">\n.flex_column.av-1cf4rlz-53ccf824e36106f16a9137172e844fdb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1cf4rlz-53ccf824e36106f16a9137172e844fdb av_one_half  avia-builder-el-127  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-1bas087-1843c8e249e2e3b8b5134b481a82ac52 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The basic and extension modules already offer more than 70 different <strong>output reports<\/strong> that can also be combined and <strong>individually<\/strong> adjusted using the options. Over 16 years of experience with device approvals of customers and designated bodies from around the world as well as several thousand device files have gone into developing the report formats. You can therefore count on the report format when using BAYOOSOFT Risk Manager and <strong>focus entirely on your content<\/strong>.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1a1nzpz-21ad49e62e58a2e1a4490802d9d5b103\">\n.flex_column.av-1a1nzpz-21ad49e62e58a2e1a4490802d9d5b103{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1a1nzpz-21ad49e62e58a2e1a4490802d9d5b103 av_one_half  avia-builder-el-129  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-186tfx3-5685543bdf4ea5b8cc956dbe8e216700 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Would you also like access to versatile formatting options, allowing you to meet your individual specifications such as special corporate identity guidelines? The <strong>Advanced Reporting<\/strong> extension module offers you a wide range of options for accessing existing reports, adapting them or preparing entirely new custom reports.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='gamp5-validation'  class='avia-section av-486w1j-2c576b32e1a313cdf335c7f0a98ccf84 main_color avia-section-default avia-no-shadow  avia-builder-el-131  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-152t5vr-292e423550a5902bcc23b559890b9f99\">\n#top .av-special-heading.av-152t5vr-292e423550a5902bcc23b559890b9f99{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-152t5vr-292e423550a5902bcc23b559890b9f99 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-152t5vr-292e423550a5902bcc23b559890b9f99 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-152t5vr-292e423550a5902bcc23b559890b9f99 av-special-heading-h2 blockquote modern-quote  avia-builder-el-132  el_before_av_one_full  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Pre-Validation Package<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-12ds5fb-d3ed0fb960cc557187ff0eec060c0ea5\">\n.flex_column.av-12ds5fb-d3ed0fb960cc557187ff0eec060c0ea5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-12ds5fb-d3ed0fb960cc557187ff0eec060c0ea5 av_one_full  avia-builder-el-133  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-10t61if-8a3a633783dbc01fdf4cdfd82dff77c5 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>All systems involved in the process need to be validated in accordance with DIN EN ISO 13485:2017. BAYOOSOFT Risk Manager has a validation process based on the GAMP 5 guidelines for computerized validation according to these requirements and is validated as category-four software. The following aspects were considered in this respect:<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-109z8on-4e3d3fcd11dc6749f3937b09dc438d03\">\n.flex_column.av-109z8on-4e3d3fcd11dc6749f3937b09dc438d03{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-109z8on-4e3d3fcd11dc6749f3937b09dc438d03 av_one_half  avia-builder-el-135  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3es2rb-5bae12c8fcce93bf2fadd66b63d44c03\">\n.avia-image-container.av-3es2rb-5bae12c8fcce93bf2fadd66b63d44c03 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-3es2rb-5bae12c8fcce93bf2fadd66b63d44c03 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-3es2rb-5bae12c8fcce93bf2fadd66b63d44c03 av-styling- avia-align-center  avia-builder-el-136  el_before_av_image  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2890 avia-img-lazy-loading-not-2890 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package.png\" alt='' title='Pre-Validation Package'  height=\"487\" width=\"1547\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package.png 1547w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-300x94.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-768x242.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-1030x324.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-1500x472.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-705x222.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-450x142.png 450w\" sizes=\"(max-width: 1547px) 100vw, 1547px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-36bajb-36b3ac7ad80c02cef49b65e9f2652a9b\">\n.avia-image-container.av-36bajb-36b3ac7ad80c02cef49b65e9f2652a9b img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-36bajb-36b3ac7ad80c02cef49b65e9f2652a9b .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-36bajb-36b3ac7ad80c02cef49b65e9f2652a9b av-styling- avia-align-center  avia-builder-el-137  el_after_av_image  avia-builder-el-last '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2896 avia-img-lazy-loading-not-2896 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png\" alt='' title='RISKMANAGER-LOGO-COLOR_II'  height=\"133\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-768x340.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1030x456.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1500x664.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-705x312.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-450x199.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-u24987-a7f83a5e28981ea42ac71912131f4c7e\">\n.flex_column.av-u24987-a7f83a5e28981ea42ac71912131f4c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-u24987-a7f83a5e28981ea42ac71912131f4c7e av_one_half  avia-builder-el-138  el_after_av_one_half  el_before_av_promobox  flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-tevx7b-517c37c33fc4d57a54d730a49304f4a2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The <strong>Pre-Validation Package<\/strong> contains the following documents:<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-qniw1z-da88b0092430af1d57cc46e5b1212652\">\n.av_font_icon.av-qniw1z-da88b0092430af1d57cc46e5b1212652{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-qniw1z-da88b0092430af1d57cc46e5b1212652 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-qniw1z-da88b0092430af1d57cc46e5b1212652 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Validation Plan<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-pgwwaf-75e2a1cef868f4489a5a734484fbea69\">\n.av_font_icon.av-pgwwaf-75e2a1cef868f4489a5a734484fbea69{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-pgwwaf-75e2a1cef868f4489a5a734484fbea69 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-pgwwaf-75e2a1cef868f4489a5a734484fbea69 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> User Requirements Specification<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-nrz6iv-e310f86ce8cf973a780d4b26efca9d31\">\n.av_font_icon.av-nrz6iv-e310f86ce8cf973a780d4b26efca9d31{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-nrz6iv-e310f86ce8cf973a780d4b26efca9d31 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-nrz6iv-e310f86ce8cf973a780d4b26efca9d31 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Supplier Audit Questionnaire<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-loq7dj-a1572abe8f3b8af1ef8182b0ac84238a\">\n.av_font_icon.av-loq7dj-a1572abe8f3b8af1ef8182b0ac84238a{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-loq7dj-a1572abe8f3b8af1ef8182b0ac84238a .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-loq7dj-a1572abe8f3b8af1ef8182b0ac84238a avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Risk Assessment<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6kwuv-713d806356c8c7f2a07036e4be7ef19e\">\n.av_font_icon.av-l6kwuv-713d806356c8c7f2a07036e4be7ef19e{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-l6kwuv-713d806356c8c7f2a07036e4be7ef19e .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-l6kwuv-713d806356c8c7f2a07036e4be7ef19e avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Functional Specification<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ii8jqv-47eea54394e22f5789dda48a29fbdae0\">\n.av_font_icon.av-ii8jqv-47eea54394e22f5789dda48a29fbdae0{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-ii8jqv-47eea54394e22f5789dda48a29fbdae0 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-ii8jqv-47eea54394e22f5789dda48a29fbdae0 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Installation Guide<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-hmjn7r-53f05d0e28b7bfea533fa02b7ba77e20\">\n.av_font_icon.av-hmjn7r-53f05d0e28b7bfea533fa02b7ba77e20{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-hmjn7r-53f05d0e28b7bfea533fa02b7ba77e20 .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-hmjn7r-53f05d0e28b7bfea533fa02b7ba77e20 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> Installation Qualification<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-gcwzev-b502fda0772f105f93265bf8e0506f6d\">\n.av_font_icon.av-gcwzev-b502fda0772f105f93265bf8e0506f6d{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-gcwzev-b502fda0772f105f93265bf8e0506f6d .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-gcwzev-b502fda0772f105f93265bf8e0506f6d avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><\/span> And many more<\/p>\n<\/div><\/section><\/div><div  class='av_promobox av-e5itw7-622929a87d0c319d42f8e0742936545b avia-button-yes  avia-builder-el-148  el_after_av_one_half  avia-builder-el-last '><div class='avia-promocontent'><p>Do you want to learn more about the contents of the Pre-Validation Package? Request an individual product presentation today or take part in one of our open webinars \u2013 specifically on validation.<\/p>\n<\/div><div  class='avia-button-wrap av-e5itw7-f903b8cb44430134f97e725a3d58d7bc-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-e5itw7-f903b8cb44430134f97e725a3d58d7bc av-link-btn avia-icon_select-no avia-size-medium avia-position-right avia-color-silver'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Arrange a consultation now\"><span class='avia_iconbox_title' >Arrange a consultation now<\/span><\/a><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-d789g7-4470989a7488625292a15b14e7ca454e\">\n.avia-section.av-d789g7-4470989a7488625292a15b14e7ca454e{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/shutterstock_682989595-1.jpg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n.avia-section.av-d789g7-4470989a7488625292a15b14e7ca454e .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_15'  class='avia-section av-d789g7-4470989a7488625292a15b14e7ca454e main_color avia-section-default avia-no-shadow  avia-builder-el-149  el_after_av_section  avia-builder-el-last  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-b65y3b-54388982f426e6be363902436b03205f\">\n#top .hr.hr-invisible.av-b65y3b-54388982f426e6be363902436b03205f{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-b65y3b-54388982f426e6be363902436b03205f hr-invisible  avia-builder-el-150  el_before_av_icon_box  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9fci1z-9b08e4ba726e2524f9bb03631faf42df\">\n.iconbox.av-9fci1z-9b08e4ba726e2524f9bb03631faf42df .iconbox_icon{\nbackground-color:#23d3bc;\nborder:1px solid #23d3bc;\ncolor:#000000;\n}\n#top #wrap_all .iconbox.av-9fci1z-9b08e4ba726e2524f9bb03631faf42df .iconbox_content_title{\ncolor:#23d3bc;\n}\n.iconbox.av-9fci1z-9b08e4ba726e2524f9bb03631faf42df .iconbox_content_container{\ncolor:#ffffff;\n}\n<\/style>\n<article  class='iconbox iconbox_left_content av-9fci1z-9b08e4ba726e2524f9bb03631faf42df  avia-builder-el-151  el_after_av_hr  el_before_av_button '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue8d2' data-av_iconfont='entypo-fontello'><\/div><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Product Presentation\"><h3 class='iconbox_content_title '  itemprop=\"headline\" >Product Presentation<\/h3><\/header><div class='iconbox_content_container av_inherit_color'  itemprop=\"text\" ><p>Curious to know more? We will be happy to show you BAYOOSOFT Risk Manager as part of a detailed product presentation. Get in touch with us today and accelerate the approval of your medical devices.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article>\n<div  class='avia-button-wrap av-7vxh2f-0ae4b43f7f405fc200f6ce9d65f09d6a-wrap avia-button-center  avia-builder-el-152  el_after_av_icon_box  el_before_av_icon_box '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-7vxh2f-0ae4b43f7f405fc200f6ce9d65f09d6a av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Arrange a consultation now\"><span class='avia_iconbox_title' >Arrange a consultation now<\/span><\/a><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ljqrr-b068310afbb9574afc4a6e0b7b065dbe\">\n.iconbox.av-ljqrr-b068310afbb9574afc4a6e0b7b065dbe .iconbox_icon{\nbackground-color:#23d3bc;\nborder:1px solid #23d3bc;\ncolor:#000000;\n}\n#top #wrap_all .iconbox.av-ljqrr-b068310afbb9574afc4a6e0b7b065dbe .iconbox_content_title{\ncolor:#23d3bc;\n}\n.iconbox.av-ljqrr-b068310afbb9574afc4a6e0b7b065dbe .iconbox_content_container{\ncolor:#ffffff;\n}\n<\/style>\n<article  class='iconbox iconbox_left_content av-ljqrr-b068310afbb9574afc4a6e0b7b065dbe  avia-builder-el-153  el_after_av_button  el_before_av_button '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue803' data-av_iconfont='entypo-fontello'><\/div><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Test for 30 days\"><h3 class='iconbox_content_title '  itemprop=\"headline\" >Test for 30 days<\/h3><\/header><div class='iconbox_content_container av_inherit_color'  itemprop=\"text\" ><p>Would you first like to try out BAYOOSOFT Risk Manager for yourself? You can thoroughly test the software solution as part of a 30-day TRIAL.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article>\n<div  class='avia-button-wrap av-3lxa0n-9988d7f0f52824493e600a88069daad0-wrap avia-button-center  avia-builder-el-154  el_after_av_icon_box  el_before_av_hr '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-3lxa0n-9988d7f0f52824493e600a88069daad0 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Request trial version now\"><span class='avia_iconbox_title' >Request trial version now<\/span><\/a><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-37u5uf-a568948d4a5f95665147122226ea0c90\">\n#top .hr.hr-invisible.av-37u5uf-a568948d4a5f95665147122226ea0c90{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-37u5uf-a568948d4a5f95665147122226ea0c90 hr-invisible  avia-builder-el-155  el_after_av_button  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":39,"featured_media":0,"parent":3090,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3095","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3095","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=3095"}],"version-history":[{"count":42,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3095\/revisions"}],"predecessor-version":[{"id":7141,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3095\/revisions\/7141"}],"up":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3090"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=3095"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}