{"id":3040,"date":"2020-06-22T15:27:58","date_gmt":"2020-06-22T13:27:58","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=3040"},"modified":"2020-08-19T14:15:25","modified_gmt":"2020-08-19T12:15:25","slug":"the-validated-approval-accelerator","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/solution\/the-validated-approval-accelerator\/","title":{"rendered":"The Validated Approval Accelerator"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-dded77b2ffc2084f3a38d8794d485a1f\">\n.avia-section.av-av_section-dded77b2ffc2084f3a38d8794d485a1f{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Risk-Manager_Screen-wide-1500x733.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-av_section-dded77b2ffc2084f3a38d8794d485a1f .av-section-color-overlay{\nopacity:0.3;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-av_section-dded77b2ffc2084f3a38d8794d485a1f 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-3040'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-eff48b44a978c70df43f332d85a7762d\">\n#top .hr.hr-invisible.av-av_hr-eff48b44a978c70df43f332d85a7762d{\nheight:500px;\n}\n<\/style>\n<div  class='hr av-av_hr-eff48b44a978c70df43f332d85a7762d 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><div id='av_section_2'  class='avia-section av-av_section-383c550227c0c1d9007994a050b6fccc alternate_color avia-section-default avia-no-shadow  avia-builder-el-2  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-3040'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-58d0c32f62c8ca31dbe5338d404b9be1\">\n#top .av-special-heading.av-av_heading-58d0c32f62c8ca31dbe5338d404b9be1{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-58d0c32f62c8ca31dbe5338d404b9be1 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-58d0c32f62c8ca31dbe5338d404b9be1 .av-subheading{\nfont-size:20px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-58d0c32f62c8ca31dbe5338d404b9be1 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  el_before_av_textblock  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >BAYOOSOFT Risk Manager \u2013 the validated approval accelerator for conveniently generating faultless technical documentation<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Accelerate the development and approval process:<br \/>\nBAYOOSOFT Risk Manager allows you to dedicate your time to the content not the process!<\/p>\n<p>International laws and ordinances, EU directives, FDA guidelines, product and process standards, guidance documents as well as quality management systems provide the foundations for BAYOOSOFT Risk Manager:<\/p>\n<\/div><\/section>\n\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_section-7ff14b2614a15ef044c6fd0afbe10626\">\n.av-tab-section-outer-container.av-av_tab_section-7ff14b2614a15ef044c6fd0afbe10626 .av-tab-section-tab-title-container{\nbackground-color:#595959;\n}\n#top .av-tab-section-outer-container.av-av_tab_section-7ff14b2614a15ef044c6fd0afbe10626 .av-section-tab-title{\ncolor:#ffffff;\n}\n<\/style>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='regulative-anforderungen'  class='av-tab-section-container entry-content-wrapper main_color av-tab-no-transition av-tab-content-auto  av-tab-above-content  avia-builder-el-5  el_after_av_section  el_before_av_section  tab-section-not-first container_wrap fullsize'  ><div class='av-tab-section-outer-container av-av_tab_section-7ff14b2614a15ef044c6fd0afbe10626'><div class='av-tab-section-tab-title-container avia-tab-title-padding-default av-custom-tab-color' role='tablist'><a href='#risk-management' data-av-tab-section-title='1' class='av-section-tab-title av-active-tab-title no-scroll av-av_tab_sub_section-327768a8b6aa894482786a79400a3fec av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-1'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Risk management<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#usability-engineering' data-av-tab-section-title='2' class='av-section-tab-title  av-av_tab_sub_section-d802de00636dbc03e886368ebbbaa0de av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-2'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Usability engineering<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#essential-requirements' data-av-tab-section-title='3' class='av-section-tab-title  av-av_tab_sub_section-8612256ab45f8bbd40b1408f6d54234a av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-3'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Essential requirements<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#medical-electrical-equipment' data-av-tab-section-title='4' class='av-section-tab-title  av-av_tab_sub_section-add3668272639537c89487cf2296138d av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-4'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Medical electrical equipment<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#medical-it-networks' data-av-tab-section-title='5' class='av-section-tab-title  av-av_tab_sub_section-8e98769803951e039e86f373ebde9cbd av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-5'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Medical IT networks<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#software-validation' data-av-tab-section-title='6' class='av-section-tab-title  av-av_tab_sub_section-83574f576186d9476d59a3bccf9754dc av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-6'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Software validation<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#clinical-evaluation' data-av-tab-section-title='7' class='av-section-tab-title  av-av_tab_sub_section-0e3e75bab64794ca48b413b0170c718d av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-7'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Clinical evaluation<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#software-lifecycle-process' data-av-tab-section-title='8' class='av-section-tab-title  av-av_tab_sub_section-1a13bd2a6891c205947cfdd31b2f433c av-tab-no-icon av-tab-no-image ' role='tab' tabindex='0' aria-controls='av-tab-section-1-8'><span class='av-outer-tab-title'><span class='av-inner-tab-title'>Software lifecycle process<\/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:800vw; 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-av_tab_sub_section-327768a8b6aa894482786a79400a3fec\">\n.av-layout-tab.av-av_tab_sub_section-327768a8b6aa894482786a79400a3fec{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-1' class='av-layout-tab av-av_tab_sub_section-327768a8b6aa894482786a79400a3fec av-animation-delay-container  avia-builder-el-6  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-management\"><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-av_heading-f72b622416ef9321ecfd108d86a9444e\">\n#top .av-special-heading.av-av_heading-f72b622416ef9321ecfd108d86a9444e{\npadding-bottom:20px;\n}\nbody .av-special-heading.av-av_heading-f72b622416ef9321ecfd108d86a9444e .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-f72b622416ef9321ecfd108d86a9444e .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-f72b622416ef9321ecfd108d86a9444e av-special-heading-h2 blockquote modern-quote  avia-builder-el-7  el_before_av_one_third  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Risk Management According to ISO 14971<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='flex_column_table av-av_one_third-67adf0f1abfc2242a214758f2160949a sc-av_one_third av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_third-67adf0f1abfc2242a214758f2160949a\">\n.flex_column.av-av_one_third-67adf0f1abfc2242a214758f2160949a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_third-67adf0f1abfc2242a214758f2160949a av_one_third  avia-builder-el-8  el_after_av_heading  el_before_av_two_third  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-a61f86115c282b9d451a9ab3cefd3aa7\">\n.avia-image-container.av-av_image-a61f86115c282b9d451a9ab3cefd3aa7 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-a61f86115c282b9d451a9ab3cefd3aa7 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-a61f86115c282b9d451a9ab3cefd3aa7 av-styling- avia-align-center  avia-builder-el-9  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-4075 avia-img-lazy-loading-not-4075 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Vorlage_ISO19471_03-08-_2020_13-04-32.png\" alt='ISO 14971 Prozess' title='Vorlage_ISO19471_03-08-_2020_13-04-32'  height=\"893\" width=\"636\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Vorlage_ISO19471_03-08-_2020_13-04-32.png 636w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Vorlage_ISO19471_03-08-_2020_13-04-32-214x300.png 214w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Vorlage_ISO19471_03-08-_2020_13-04-32-502x705.png 502w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Vorlage_ISO19471_03-08-_2020_13-04-32-450x632.png 450w\" sizes=\"(max-width: 636px) 100vw, 636px\" \/><\/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-av_two_third-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_two_third-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_two_third-c8fc129dc35fd1ae2a1e410224d39ea8 av_two_third  avia-builder-el-10  el_after_av_one_third  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>A medical device is used on or inside patients and involves a certain degree of risk. Here, a particularly high level of protection is required. Any residual risk must therefore be weighed up against the benefits of the device. For this reason, German, European and American law for medical devices consistently requires <strong>risk management for medical devices and in-vitro diagnostics<\/strong>.<\/p>\n<p>The internationally valid standard <strong>ISO 14971<\/strong> stipulates a procedure to this end, which identifies the hazards associated with medical devices and their accessories, assesses, rates and controls the risks and monitors the effectiveness of these controls. The requirements of the standard are applicable throughout all phases of the product lifecycle for a medical device.<\/p>\n<p>BAYOOSOFT Risk Manager is the globally leading and validated software product for the fully integrated generation of risk management documents according to ISO 14971. All relevant information is recorded in a clearly structured environment, stored in a central, audit-proof manner and dynamically connected with each other at a fine-grained level. You can freely choose whether to perform your risk management based on <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#failure-mode-and-effect-analysis\">FMEA according to DIN EN IEC 60812<\/a> or a <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#preliminary-hazard-analysis\">preliminary hazard analysis (PHA)<\/a>. Integrated project and version management with a fine-grained authorization structure, monitoring of measure management including validation and verification, performance of risk inventory with an automated reminder function and integrated template management with a self-learning knowledge database as well as automated suggestion functions \u2013 such as for identifying particularly effective measures \u2013 significantly accelerate and simplify the preparation of risk management documents.<\/p>\n<p>BAYOOSOFT Risk Manager meets the requirements of FDA 21 CFR Part 11.<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_sub_section-d802de00636dbc03e886368ebbbaa0de\">\n.av-layout-tab.av-av_tab_sub_section-d802de00636dbc03e886368ebbbaa0de{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-2' class='av-layout-tab av-av_tab_sub_section-d802de00636dbc03e886368ebbbaa0de av-animation-delay-container  avia-builder-el-12  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"2\" data-tab-section-id=\"usability-engineering\"><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-av_heading-63a488fbb4667fa57949c3eb6a2d6f22\">\n#top .av-special-heading.av-av_heading-63a488fbb4667fa57949c3eb6a2d6f22{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-63a488fbb4667fa57949c3eb6a2d6f22 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-63a488fbb4667fa57949c3eb6a2d6f22 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-63a488fbb4667fa57949c3eb6a2d6f22 av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Usability Engineering According to EN 62366<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='flex_column_table av-av_one_half-1f15b01c231f8b34e1362c844f22d166 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-1f15b01c231f8b34e1362c844f22d166\">\n.flex_column.av-av_one_half-1f15b01c231f8b34e1362c844f22d166{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-1f15b01c231f8b34e1362c844f22d166 av_one_half  avia-builder-el-14  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-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager fully integrates the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#usability-engineering-en62366-en60601-1-6\">usability engineering process<\/a> into risk management in accordance with ISO 14971 and guides you step by step to the usability engineering file based on a tried and tested macrostructure. From intended usage conditions and medical indications, intended patient and user groups, usage scenarios and main usage functions and requirements through to summative evaluations plans and formative evaluation, 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><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-16  el_after_av_one_half  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-av-av_image-88e5db6c4fcf018b194e2dbbfc13f290\">\n.avia-image-container.av-av_image-88e5db6c4fcf018b194e2dbbfc13f290 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-88e5db6c4fcf018b194e2dbbfc13f290 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-88e5db6c4fcf018b194e2dbbfc13f290 av-styling- avia-align-center  avia-builder-el-17  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-3720 avia-img-lazy-loading-not-3720 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2.png\" alt='' title='Summative Evaluation Plan'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Summative-Evaluation-Plan-2-450x281.png 450w\" sizes=\"(max-width: 1680px) 100vw, 1680px\" \/><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-av_promobox-07cb8cbdee0156c85a3ada82a017e9d0 avia-button-yes  avia-builder-el-18  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-av_button-3908e58fc9f67a7532c83feae0ee38a7-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-av_button-3908e58fc9f67a7532c83feae0ee38a7 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-av_tab_sub_section-8612256ab45f8bbd40b1408f6d54234a\">\n.av-layout-tab.av-av_tab_sub_section-8612256ab45f8bbd40b1408f6d54234a{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-3' class='av-layout-tab av-av_tab_sub_section-8612256ab45f8bbd40b1408f6d54234a av-animation-delay-container  avia-builder-el-19  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=\"essential-requirements\"><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-av_heading-63e668cb25eb1e0dd60d2dcb1a5b0648\">\n#top .av-special-heading.av-av_heading-63e668cb25eb1e0dd60d2dcb1a5b0648{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-63e668cb25eb1e0dd60d2dcb1a5b0648 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-63e668cb25eb1e0dd60d2dcb1a5b0648 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-63e668cb25eb1e0dd60d2dcb1a5b0648 av-special-heading-h2 blockquote modern-quote  avia-builder-el-20  el_before_av_two_fifth  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><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_two_fifth-15d750bd1b332b34c6e70b077ebbccdf\">\n.flex_column.av-av_two_fifth-15d750bd1b332b34c6e70b077ebbccdf{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_two_fifth-15d750bd1b332b34c6e70b077ebbccdf av_two_fifth  avia-builder-el-21  el_after_av_heading  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-bb9ce5636d8769a4b7ff832fd0bb6576\">\n.avia-image-container.av-av_image-bb9ce5636d8769a4b7ff832fd0bb6576 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-bb9ce5636d8769a4b7ff832fd0bb6576 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-bb9ce5636d8769a4b7ff832fd0bb6576 av-styling- avia-align-center  avia-builder-el-22  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-4099 avia-img-lazy-loading-not-4099 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements.png\" alt='' title='IVD-Screenshot_ENG - Essential Requirements'  height=\"805\" width=\"847\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements.png 847w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements-300x285.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements-768x730.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements-705x670.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IVD-Screenshot_ENG-Essential-Requirements-450x428.png 450w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8 av_three_fifth  avia-builder-el-23  el_after_av_two_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In order to bring a medical device into circulation in the European market, it needs to comply with the \u201cessential requirements\u201d of the applicable directives. EU regulations apply in this context:<\/p>\n<p><a href=\"https:\/\/www.riskmanager.net\/en\/solution\/the-validated-approval-accelerator\/#clinical-evaluation\">Medical Device Regulation<\/a> \/ MDR 2017\/745 for medical products and active implantable medical devices<br \/>\n<strong>In-Vitro Diagnostics Medical Device Regulation<\/strong> \/ IVDR 2017\/746 for in-vitro diagnostics<\/p>\n<p>What\u2019s more, additional regulations may need to be observed depending on the type of device. In each member state of the European Union and in the associated countries, these EU regulations prevail over national legislation.<\/p>\n<p>In practice, depending on the device type, questions need to be answered regarding product design in relation to the principles of integrated safety, the elimination or minimization of risks, user information about residual risks for which no appropriate protective measures may be taken, storage and transport, chemical and biological properties, requirements on construction and manufacture, infection and microbial contamination, environmental conditions, protection against radiation or mechanical and thermal risks, protection against risks resulting from the release of energy or substances to patients, product requirements for self-administration and labeling.<\/p>\n<p>In the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#essential-requirements-mdr-ivdr\">Essential Requirements<\/a> extension module, BAYOOSOFT Risk Manager incorporates the rules of the normative requirements of MDR 2017\/745 and IVDR 2017\/746, guides the user with smart questions regarding relevant points and refers to existing information from risk management, therebhttps:\/\/www.riskmanager.net\/modules-features\/modules\/?lang=en\/#essential-requirements-mdr-ivdry preventing duplicated data capture and documenting this in auditable reports accepted by designated bodies.<\/p>\n<\/div><\/section><\/div><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_sub_section-add3668272639537c89487cf2296138d\">\n.av-layout-tab.av-av_tab_sub_section-add3668272639537c89487cf2296138d{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-4' class='av-layout-tab av-av_tab_sub_section-add3668272639537c89487cf2296138d av-animation-delay-container  avia-builder-el-25  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=\"medical-electrical-equipment\"><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-av_heading-b781c36f6e61415ddab4bbeb35e9e967\">\n#top .av-special-heading.av-av_heading-b781c36f6e61415ddab4bbeb35e9e967{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-b781c36f6e61415ddab4bbeb35e9e967 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-b781c36f6e61415ddab4bbeb35e9e967 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-b781c36f6e61415ddab4bbeb35e9e967 av-special-heading-h2 blockquote modern-quote  avia-builder-el-26  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Conformity Report for Medical Electrical Equipment According to EN 60601-1<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='flex_column_table av-av_one_half-1f15b01c231f8b34e1362c844f22d166 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-1f15b01c231f8b34e1362c844f22d166\">\n.flex_column.av-av_one_half-1f15b01c231f8b34e1362c844f22d166{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-1f15b01c231f8b34e1362c844f22d166 av_one_half  avia-builder-el-27  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-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>A conformity report pursuant to IEC EN 60601-1 needs to be created for medical electrical equipment. Depending on the device type, collateral standards (EN 60601-1-x) and particular standards (EN 60601-2-y) also apply.<\/p>\n<p>Edition 3.1 of IEC 60601-1 represents a complete revision in which the importance of risk management is significantly raised. Risk management pursuant to ISO 14971 is thus an important element of the safety concept of medical devices. To avoid redundant and contradictory data inventories, the manufacturers of medical electrical equipment face the challenge of introducing an efficient and safe process here.<\/p>\n<p>In addition to this complex challenge, more than 1,500 applicability tests need to be considered and substantiated with test protocols. BAYOOSOFT Risk Manager simplifies this process substantially and creates the full conformity report for you in accordance with IEC\u00a060601-1. Duplicate collections are completely avoided and non-relevant tests are automatically filtered out via intelligent querying. You are interactively guided through the entire standardization process.<\/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-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-29  el_after_av_one_half  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-av-av_image-098734c158c1ebddb6537b8b9399581b\">\n.avia-image-container.av-av_image-098734c158c1ebddb6537b8b9399581b img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-098734c158c1ebddb6537b8b9399581b .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-098734c158c1ebddb6537b8b9399581b av-styling- avia-align-center  avia-builder-el-30  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-3722 avia-img-lazy-loading-not-3722 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1.png\" alt='' title='1-4'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-4-1-450x281.png 450w\" sizes=\"(max-width: 1680px) 100vw, 1680px\" \/><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-av_promobox-07cb8cbdee0156c85a3ada82a017e9d0 avia-button-yes  avia-builder-el-31  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-av_button-3908e58fc9f67a7532c83feae0ee38a7-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-av_button-3908e58fc9f67a7532c83feae0ee38a7 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-av_tab_sub_section-8e98769803951e039e86f373ebde9cbd\">\n.av-layout-tab.av-av_tab_sub_section-8e98769803951e039e86f373ebde9cbd{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-5' class='av-layout-tab av-av_tab_sub_section-8e98769803951e039e86f373ebde9cbd av-animation-delay-container  avia-builder-el-32  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"5\" data-tab-section-id=\"medical-it-networks\"><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-av_heading-fa942b1fff922dfe8378345de6f0eb28\">\n#top .av-special-heading.av-av_heading-fa942b1fff922dfe8378345de6f0eb28{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-fa942b1fff922dfe8378345de6f0eb28 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-fa942b1fff922dfe8378345de6f0eb28 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-fa942b1fff922dfe8378345de6f0eb28 av-special-heading-h2 blockquote modern-quote  avia-builder-el-33  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Risikomanagement f\u00fcr IT-Netzwerke nach IEC 80001-1<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='flex_column_table av-av_one_half-1f15b01c231f8b34e1362c844f22d166 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-1f15b01c231f8b34e1362c844f22d166\">\n.flex_column.av-av_one_half-1f15b01c231f8b34e1362c844f22d166{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-1f15b01c231f8b34e1362c844f22d166 av_one_half  avia-builder-el-34  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-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div class=\"av-special-heading av-special-heading-h2 blockquote modern-quote avia-builder-el-98 el_before_av_textblock avia-builder-el-first \">\n<h2>Risk Management for IT Networks According to IEC 80001-1<\/h2>\n<p>The term <strong>medical IT network<\/strong> includes all IT networks that contain at least one medical device as a component. IEC 80001-1 is therefore directed at all operators of such networks, with the aim that they deal with the <strong>safety aspects<\/strong> of IT and medical technology.<\/p>\n<p>In particular, the standard requires <strong>risk management throughout the entire lifecycle<\/strong> of the IT network \u2013 from integration through to the separation of the medical device from the network. After all, a large number of problem cases can already be identified and resolved in advance using systematic risk analysis. According to IEC 80001-1, special protection goals need to be considered for this risk management as well as corresponding risk management documents prepared.<\/p>\n<\/div>\n<div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-373523e22f0366b13a549278f1ad345e\">\n#top .hr.hr-invisible.av-av_hr-373523e22f0366b13a549278f1ad345e{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-av_hr-373523e22f0366b13a549278f1ad345e hr-invisible  avia-builder-el-36  el_before_av_font_icon  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<\/div>\n<div><\/div>\n<h5>Protection goals for medical IT networks<\/h5>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_font_icon-c7930a7b7edbb21c970428aff98f04de\">\n.av_font_icon.av-av_font_icon-c7930a7b7edbb21c970428aff98f04de .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-av_font_icon-c7930a7b7edbb21c970428aff98f04de avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span> Safety<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_font_icon-c7930a7b7edbb21c970428aff98f04de\">\n.av_font_icon.av-av_font_icon-c7930a7b7edbb21c970428aff98f04de .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-av_font_icon-c7930a7b7edbb21c970428aff98f04de avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span> Effectiveness<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_font_icon-c7930a7b7edbb21c970428aff98f04de\">\n.av_font_icon.av-av_font_icon-c7930a7b7edbb21c970428aff98f04de .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-av_font_icon-c7930a7b7edbb21c970428aff98f04de avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span> Data protection<\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_font_icon-c7930a7b7edbb21c970428aff98f04de\">\n.av_font_icon.av-av_font_icon-c7930a7b7edbb21c970428aff98f04de .av-icon-char{\nfont-size:20px;\nline-height:20px;\n}\n<\/style>\n<span  class='av_font_icon av-av_font_icon-c7930a7b7edbb21c970428aff98f04de avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span> System security<\/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-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-41  el_after_av_one_half  el_before_av_textblock  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-av-av_image-3725eadf05efa83366fda6e16d5ec808\">\n.avia-image-container.av-av_image-3725eadf05efa83366fda6e16d5ec808 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-3725eadf05efa83366fda6e16d5ec808 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-3725eadf05efa83366fda6e16d5ec808 av-styling- avia-align-center  avia-builder-el-42  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-2970 avia-img-lazy-loading-not-2970 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-1030x687.jpg\" alt='' title='shutterstock_589601687'  height=\"687\" width=\"1030\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-705x470.jpg 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_589601687-450x300.jpg 450w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As the market-leading solution for risk management, BAYOOSOFT Risk Manager supports you in fulfilling these risk management requirements. This allows you to take care of all requirements, manufacturers, network components, changes and monitoring at a central place. All information is stored in a central, auditable manner and dynamically connected with each other at a fine-grained level. Reports are generated with the most up-to-date data at the press of a button. This way, you can focus your valuable time on the content, not the process.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_sub_section-83574f576186d9476d59a3bccf9754dc\">\n.av-layout-tab.av-av_tab_sub_section-83574f576186d9476d59a3bccf9754dc{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-6' class='av-layout-tab av-av_tab_sub_section-83574f576186d9476d59a3bccf9754dc av-animation-delay-container  avia-builder-el-44  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"6\" data-tab-section-id=\"software-validation\"><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-av_heading-5ce687ad9bd361303cd1c7d1d3fbcd99\">\n#top .av-special-heading.av-av_heading-5ce687ad9bd361303cd1c7d1d3fbcd99{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-5ce687ad9bd361303cd1c7d1d3fbcd99 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-5ce687ad9bd361303cd1c7d1d3fbcd99 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-5ce687ad9bd361303cd1c7d1d3fbcd99 av-special-heading-h2 blockquote modern-quote  avia-builder-el-45  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Process Validation According to DIN EN ISO 13485<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The validation of computerized systems becomes a fundamental component of the quality management system with the medical device standard ISO 13485:2016. This ensures transparency and consistency in safety-critical processes and environments. For instance, evidence must be provided that the software specifications conform to user requirements and fulfill the intended purpose.<\/p>\n<p>For manufacturers that use their own solutions like Microsoft Excel or Word files in development, for example in risk management or product documentation, this means that they have to validate these solutions. The costs of this validation can quickly exceed 150 hours of work depending on the scope of the sheets and the existing know-how. Moreover, revalidation needs to be carried out for every change to templates or the system.<\/p>\n<p>To save you this often unproductive work, BAYOOSOFT Risk Manager has been validated based on the GAMP 5 guidelines for computerized validation as category-four software. The validation documents generated from this process are now available to you as a pre-validation package. The pre-validation package enables you to benefit from the following:<\/p>\n<\/div><\/section><br \/>\n<div class='flex_column_table av-av_two_fifth-1f15b01c231f8b34e1362c844f22d166 sc-av_two_fifth av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_two_fifth-1f15b01c231f8b34e1362c844f22d166\">\n.flex_column.av-av_two_fifth-1f15b01c231f8b34e1362c844f22d166{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_two_fifth-1f15b01c231f8b34e1362c844f22d166 av_two_fifth  avia-builder-el-47  el_after_av_textblock  el_before_av_three_fifth  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-e7b38ba4550a5fc0851a3a2ed050375d\">\n.avia-image-container.av-av_image-e7b38ba4550a5fc0851a3a2ed050375d img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-e7b38ba4550a5fc0851a3a2ed050375d .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-e7b38ba4550a5fc0851a3a2ed050375d av-styling- avia-align-center  avia-builder-el-48  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-av_image-24f91ebc08052ebc298e58de7bcb44a2\">\n.avia-image-container.av-av_image-24f91ebc08052ebc298e58de7bcb44a2 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-24f91ebc08052ebc298e58de7bcb44a2 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-24f91ebc08052ebc298e58de7bcb44a2 av-styling- avia-align-center  avia-builder-el-49  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><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_three_fifth-c8fc129dc35fd1ae2a1e410224d39ea8 av_three_fifth  avia-builder-el-50  el_after_av_two_fifth  el_before_av_promobox  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  column-top-margin'     ><div  class='avia-icon-list-container av-av_iconlist-7f4c0e5acb79a3bde7d7887b2acfa62d  avia-builder-el-51  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-av_iconlist-7f4c0e5acb79a3bde7d7887b2acfa62d avia-iconlist-animate'>\n<li><div class='iconlist_icon av-av_iconlist_item-d786bd7ce1778628b1330f0ba09fcf9f avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue863' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Time savings\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Time savings<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>As part of the pre-validation package, you receive a quick-start guide that helps you perform the validation process quickly and effectively.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-fa8569a101bd4807f6c3123280788074 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue849' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Streamlined processes and cost savings\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Streamlined processes and cost savings<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>You receive validation work prepared on over 500 pages for your sustainable and compliant documents.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-4d860a4618bab0e81ba0e1ea6f52bc1a avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue866' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Sustainability included\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Sustainability included<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>All necessary updates are provided with each software patch for revalidation.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-bfbeb746b1c62a8def92206056717f84 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Special service\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Special service<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>With our special service package, we handle the validation of BAYOOSOFT Risk Manager for you according to GAMP 5 upon request.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-av_promobox-cdca47ba18270243d4e5cd7a62686cf4 avia-button-yes  avia-builder-el-52  el_after_av_three_fifth  avia-builder-el-last '><div class='avia-promocontent'><p>\nDo you need assistance in validating the software solution? Find out about our extra services.<\/p>\n<\/div><div  class='avia-button-wrap av-av_button-fb2057bb1971b26d0a7aae2b1f212c29-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/#validation_services'  class='avia-button av-av_button-fb2057bb1971b26d0a7aae2b1f212c29 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Book services now \"><span class='avia_iconbox_title' >Book services 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-av_tab_sub_section-0e3e75bab64794ca48b413b0170c718d\">\n.av-layout-tab.av-av_tab_sub_section-0e3e75bab64794ca48b413b0170c718d{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-7' class='av-layout-tab av-av_tab_sub_section-0e3e75bab64794ca48b413b0170c718d av-animation-delay-container  avia-builder-el-53  el_after_av_tab_sub_section  el_before_av_tab_sub_section  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"7\" data-tab-section-id=\"clinical-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-av_heading-0282e63c03a712107a0fe8b1f08f37cd\">\n#top .av-special-heading.av-av_heading-0282e63c03a712107a0fe8b1f08f37cd{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-0282e63c03a712107a0fe8b1f08f37cd .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-0282e63c03a712107a0fe8b1f08f37cd .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-0282e63c03a712107a0fe8b1f08f37cd av-special-heading-h2 blockquote modern-quote  avia-builder-el-54  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  > Clinical Evaluation According to MDR 2017\/745 <span class='special_amp'>&amp;<\/span> MEDDEV 2.7.1<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><blockquote>\n<p><strong>Clinical evaluation according to MDR:<\/strong> \u201crefers to a systematic and planned process for the continuous generation, collection, analysis and evaluation of clinical data for a product, whereby the <strong>safety<\/strong> and <strong>performance<\/strong> including the <strong>clinical benefit<\/strong> of the product are examined in connection with the intended use defined by the manufacturer.\u201d<\/p>\n<\/blockquote>\n<\/div><\/section><br \/>\n<div class='flex_column_table av-av_one_half-67adf0f1abfc2242a214758f2160949a sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-67adf0f1abfc2242a214758f2160949a\">\n.flex_column.av-av_one_half-67adf0f1abfc2242a214758f2160949a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-67adf0f1abfc2242a214758f2160949a av_one_half  avia-builder-el-56  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'     ><p><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The clinical evaluation is also part of the quality management system, since all necessary information about the entire lifecycle is documented. This results in the requirements applicable to you as a manufacturer of medical devices to specify and justify the scope of the clinical evidence based on the product characteristics and intended purpose. Here, a precisely defined procedure needs to be fulfilled, with consideration paid to the following:<\/p>\n<ul>\n<li>Critical evaluation of the specialist scientific literature<\/li>\n<li>Critical evaluation of the results of all available clinical tests<\/li>\n<li>Consideration of other treatment options for the same purpose<\/li>\n<\/ul>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-av_button-a486442917b5642ce19808e25b123674-wrap avia-button-center  avia-builder-el-58  el_after_av_textblock  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-av_button-a486442917b5642ce19808e25b123674 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Find out more now\"><span class='avia_iconbox_title' >Find out more now<\/span><\/a><\/div><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-59  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  column-top-margin'     ><p><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>To support you in this continuous process as best as possible, BAYOOSOFT Risk Manager offers you a solution compliant with <strong>MDR<\/strong> and <strong>MEDDEV 2.7.1 rev4<\/strong> in the extension module \u201cClinical Evaluation\u201d. 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><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-f6f026b9e56ec523fc90422b9e593172\">\n.avia-image-container.av-av_image-f6f026b9e56ec523fc90422b9e593172 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-f6f026b9e56ec523fc90422b9e593172 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-f6f026b9e56ec523fc90422b9e593172 av-styling- avia-align-center  avia-builder-el-61  el_after_av_textblock  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-4106 avia-img-lazy-loading-not-4106 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation.png\" alt='Process Clinical Evaluation' title='Process Clinical Evaluation'  height=\"587\" width=\"1731\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation.png 1731w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-300x102.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-1030x349.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-768x260.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-1536x521.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-1500x509.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-705x239.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Process-Clinical-Evaluation-450x153.png 450w\" sizes=\"(max-width: 1731px) 100vw, 1731px\" \/><\/div><\/div><\/div><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/p>\n<\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_sub_section-1a13bd2a6891c205947cfdd31b2f433c\">\n.av-layout-tab.av-av_tab_sub_section-1a13bd2a6891c205947cfdd31b2f433c{\nvertical-align:top;\n}\n<\/style>\n<div id='av-tab-section-1-8' class='av-layout-tab av-av_tab_sub_section-1a13bd2a6891c205947cfdd31b2f433c av-animation-delay-container  avia-builder-el-62  el_after_av_tab_sub_section  avia-builder-el-last  ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"8\" data-tab-section-id=\"software-lifecycle-process\"><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-av_heading-da526ae1fef7eea0b7d3c65385a53d7b\">\n#top .av-special-heading.av-av_heading-da526ae1fef7eea0b7d3c65385a53d7b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-da526ae1fef7eea0b7d3c65385a53d7b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-da526ae1fef7eea0b7d3c65385a53d7b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-da526ae1fef7eea0b7d3c65385a53d7b av-special-heading-h2 blockquote modern-quote  avia-builder-el-63  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Software Lifecycle Process According to IEC 62304<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf\">\n.flex_column.av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf av_one_half  avia-builder-el-64  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>IEC 62304 \u201cMedical devices software \u2013 software lifecycle processes\u201d describes how software for medical devices should be developed and what role risk management should play. It is based on DIN EN ISO 14971. As an international standard, IEC 62304 is relevant to all manufacturers that use software in their medical devices \u2013 no matter whether the software is embedded or if the medical device consists of stand-alone software.<\/p>\n<p>Here, IEC 62304 sets forth a general framework for the lifecycle process of medical device software by defining requirements for the composition of processes, activities and tasks. Specifically, five topical areas are addressed which are referred to as \u201cprocesses\u201d in the language of the standard:<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_iconlist-2cfdc7961a9f90b4daba7e89294f718b\">\n#top .avia-icon-list-container.av-av_iconlist-2cfdc7961a9f90b4daba7e89294f718b .iconlist_icon{\ncolor:#4abaab;\n}\n<\/style>\n<div  class='avia-icon-list-container av-av_iconlist-2cfdc7961a9f90b4daba7e89294f718b  avia-builder-el-66  el_after_av_textblock  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-av_iconlist-2cfdc7961a9f90b4daba7e89294f718b avia-iconlist-animate'>\n<li><div class='iconlist_icon av-av_iconlist_item-8a00c603aa5c77755e1d154cbb9a04a1 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' 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: Software development\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Software development<\/div><\/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-av_iconlist_item-ae4b6c190dbc38ae8118be6b97d515c8 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' 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: Software maintenance\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Software maintenance<\/div><\/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-av_iconlist_item-39c7bb6683b1e3eabe98a456ec3d4a4d avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' 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: Software risk management\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Software risk management<\/div><\/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-av_iconlist_item-a44d214f1dad137822a9ce690885c874 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' 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: Software configuration management\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Software configuration management<\/div><\/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-av_iconlist_item-241cf06e9744a5e1e8982132fba4d6bd avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue808' 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: Problem solving for software\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Problem solving for software<\/div><\/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-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-67  el_after_av_one_half  el_before_av_promobox  flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The standard primarily requires preparing and maintaining a risk analysis as an integral component of the development process. Compliance with the normative specifications is determined by viewing the entire documentation, including risk management documents, as well as by assessing the processes, activities and tasks required for the corresponding software safety category.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-5c4cd518aa0f1533d36d7f34d9013c66\">\n.avia-image-container.av-av_image-5c4cd518aa0f1533d36d7f34d9013c66 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-5c4cd518aa0f1533d36d7f34d9013c66 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-5c4cd518aa0f1533d36d7f34d9013c66 av-styling- avia-align-center  avia-builder-el-69  el_after_av_textblock  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-4068 avia-img-lazy-loading-not-4068 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN.png\" alt='' title='IEC620304 (EN)'  height=\"913\" width=\"1704\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN.png 1704w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-300x161.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-1030x552.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-768x411.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-1536x823.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-1500x804.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-705x378.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/IEC620304-EN-450x241.png 450w\" sizes=\"(max-width: 1704px) 100vw, 1704px\" \/><\/div><\/div><\/div><\/p><\/div><div  class='av_promobox av-av_promobox-2015e921363ddef705a63f028d175d81 avia-button-yes  avia-builder-el-70  el_after_av_one_half  avia-builder-el-last '><div class='avia-promocontent'><p>\nBAYOOSOFT Risk Manager helps you in particular with combining risk management and product design for your medical device.<\/p>\n<\/div><div  class='avia-button-wrap av-av_button-0b152adfa1e5f2c4101c790198a8ef59-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304'  class='avia-button av-av_button-0b152adfa1e5f2c4101c790198a8ef59 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'   aria-label=\"Find out more now\"><span class='avia_iconbox_title' >Find out more now<\/span><\/a><\/div><\/div><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-77a6d8ebb8bc6f5c74d44b7a50c2717e\">\n.avia-section.av-av_section-77a6d8ebb8bc6f5c74d44b7a50c2717e{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Risk-Manager_Screen-wide-1500x733.jpg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n.avia-section.av-av_section-77a6d8ebb8bc6f5c74d44b7a50c2717e .av-section-color-overlay{\nopacity:0.3;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-av_section-77a6d8ebb8bc6f5c74d44b7a50c2717e alternate_color avia-section-default avia-no-shadow  avia-builder-el-71  el_after_av_tab_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-3040'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-1deae294de86921cadf9622fb2da0879\">\n#top .hr.hr-invisible.av-av_hr-1deae294de86921cadf9622fb2da0879{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-av_hr-1deae294de86921cadf9622fb2da0879 hr-invisible  avia-builder-el-72  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Curious to know more? 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