{"id":3197,"date":"2020-06-29T11:36:25","date_gmt":"2020-06-29T09:36:25","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=3197"},"modified":"2020-12-01T09:57:28","modified_gmt":"2020-12-01T08:57:28","slug":"features","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/","title":{"rendered":"Features"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-dbd2cac4c680cbd7d30955e53ccba21b\">\n.avia-section.av-av_section-dbd2cac4c680cbd7d30955e53ccba21b{\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-av_section-dbd2cac4c680cbd7d30955e53ccba21b .av-section-color-overlay{\nopacity:0.4;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-av_section-dbd2cac4c680cbd7d30955e53ccba21b 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-3197'><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='guiding-principles'  class='avia-section av-av_section-24abbf6fa5892e1a2abbd8cabaa3fed9 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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-3e5f6fb13a2408bd818093695a098dd3\">\n#top .av-special-heading.av-av_heading-3e5f6fb13a2408bd818093695a098dd3{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-3e5f6fb13a2408bd818093695a098dd3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-3e5f6fb13a2408bd818093695a098dd3 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-3e5f6fb13a2408bd818093695a098dd3 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  el_before_av_hr  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\"  >Core features for faultless technical documentation<\/h1><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-av_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-4  el_after_av_heading  el_before_av_one_half '><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-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-5  el_after_av_hr  el_before_av_one_half  first 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><strong><em>BAYOOSOFT Risk Manager<\/em><\/strong> is the validated approval accelerator for preparing technical documentation for manufacturers of medical devices and in-vitro diagnostics. 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. No redundant data exists. Reports are automatically generated with up-to-date data at the <strong>press of a button.<\/strong><\/p>\n<p>The intuitive user guidance, examples provided and ready-made document templates make it easy to get started. The<strong> self-learning knowledge database<\/strong> results in synergy effects between projects and helps to utilize developed know-how throughout the company. At the same time, BAYOOSOFT Risk Manager meets the requirements of FDA 21 <strong>CFR Part 11.<\/strong><\/p>\n<p>A clear and consistent approach with the reliable application accelerates market approval and has a positive effect on expended time and costs: Our customer base of more than 800 customers reported up to <strong>62% faster approvals<\/strong> for medical devices thanks to BAYOOSOFT Risk Manager.<\/p>\n<p>These key features provide the foundations for conveniently generating technical documentation. Find out more:<\/p>\n<\/div><\/section><\/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-7  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><div  class='avia-icon-list-container av-av_iconlist-b9622264be8b33ecf932b804b1272287  avia-builder-el-8  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-av_iconlist-b9622264be8b33ecf932b804b1272287 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-av_iconlist_item-db8c57443624f275fa9ed061533fb7db avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue84d' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#preliminary-hazard-analysis&#039; title=&#039;Preliminary hazard analysis&#039;&gt;Preliminary hazard analysis&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#preliminary-hazard-analysis' title='Preliminary hazard analysis'>Preliminary hazard analysis<\/a><\/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-av_iconlist_item-85a599023c419f794473f94d6b6db570 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue850' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#failure-mode-and-effect-analysis&#039; title=&#039;Failure mode and effect analysis&#039;&gt;Failure mode and effect analysis&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#failure-mode-and-effect-analysis' title='Failure mode and effect analysis'>Failure mode and effect analysis<\/a><\/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-av_iconlist_item-ff86d1289dc682cac4dc5ea3897550b1 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8d1' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#lifecycle-phase&#039; title=&#039;Structured work according to lifecycle phase&#039;&gt;Structured work according to lifecycle phase&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#lifecycle-phase' title='Structured work according to lifecycle phase'>Structured work according to lifecycle phase<\/a><\/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-av_iconlist_item-cd8d85d113aa79f2926c8cd29e77b2b8 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8bb' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#mdr-classification&#039; title=&#039;Medical device classification&#039;&gt;Medical device classification&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#mdr-classification' title='Medical device classification'>Medical device classification<\/a><\/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-av_iconlist_item-d67dce1ac2f84eb8aa9c996b5df49014 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue80b' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#post-market-surveillance&#039; title=&#039;Post-market surveillance&#039;&gt;Post-market surveillance&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#post-market-surveillance' title='Post-market surveillance'>Post-market surveillance<\/a><\/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-av_iconlist_item-801be209eeda7ae77e99b4054048a4dd avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8ab' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#self-learning-knowledge-database&#039; title=&#039;Self-learning knowledge database&#039;&gt;Self-learning knowledge database&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#self-learning-knowledge-database' title='Self-learning knowledge database'>Self-learning knowledge database<\/a><\/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-av_iconlist_item-323759c51878f1950d03cd64e48be875 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue82b' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#fine-grained-authorization-management&#039; title=&#039;Fine-grained authorization management&#039;&gt;Fine-grained authorization management&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#fine-grained-authorization-management' title='Fine-grained authorization management'>Fine-grained authorization management<\/a><\/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-av_iconlist_item-ae20392242c913d451bbe8608fb9c20a avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue80d' 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: &lt;a href=&#039;\/en\/modules-features\/features\/#greybox&#039; title=&#039;Visualizing with the grey box&#039;&gt;Visualizing with the grey box&lt;\/a&gt;\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" ><a href='\/en\/modules-features\/features\/#greybox' title='Visualizing with the grey box'>Visualizing with the grey box<\/a><\/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><\/div>\n\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_tab_section-28933ec1ac79327cfc52998ec7b871ad\">\n.av-tab-section-outer-container.av-av_tab_section-28933ec1ac79327cfc52998ec7b871ad .av-tab-section-tab-title-container{\nbackground-color:#595959;\n}\n#top .av-tab-section-outer-container.av-av_tab_section-28933ec1ac79327cfc52998ec7b871ad .av-section-tab-title{\ncolor:#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-slide-transition   av-tab-above-content  avia-builder-el-9  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-28933ec1ac79327cfc52998ec7b871ad'><div class='av-tab-section-tab-title-container avia-tab-title-padding-default av-custom-tab-color' role='tablist'><a href='#preliminary-hazard-analysis' data-av-tab-section-title='1' class='av-section-tab-title av-active-tab-title no-scroll av-av_tab_sub_section-529ddfbf3c3f77ceaea21d08d5f0734f 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'>Preliminary Hazard Analysis<\/span><\/span><span class=\"av-tab-arrow-container\"><span><\/span><\/span><\/a><a href='#failure-mode-and-effect-analysis' data-av-tab-section-title='2' class='av-section-tab-title  av-av_tab_sub_section-2cbf963fb40c64712b92106a92606699 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'>Failure Mode and Effect Analysis<\/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:200vw; 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-529ddfbf3c3f77ceaea21d08d5f0734f\">\n.av-layout-tab.av-av_tab_sub_section-529ddfbf3c3f77ceaea21d08d5f0734f{\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_127004546-1500x1140.jpg);\nbackground-position:center center;\nbackground-repeat:no-repeat;\nbackground-attachment:fixed;\nvertical-align:middle;\n}\n<\/style>\n<div id='av-tab-section-1-1' class='av-layout-tab av-av_tab_sub_section-529ddfbf3c3f77ceaea21d08d5f0734f av-animation-delay-container  avia-builder-el-10  el_before_av_tab_sub_section  avia-builder-el-first  avia-full-stretch av-active-tab-content __av_init_open ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"1\" data-tab-section-id=\"preliminary-hazard-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-av_heading-5cc404e1b1f17a1ca0641221fbb68476\">\n#top .av-special-heading.av-av_heading-5cc404e1b1f17a1ca0641221fbb68476{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-5cc404e1b1f17a1ca0641221fbb68476 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-5cc404e1b1f17a1ca0641221fbb68476 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-5cc404e1b1f17a1ca0641221fbb68476 av-special-heading-h2 blockquote modern-quote  avia-builder-el-11  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Preliminary Hazard Analysis<\/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_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-12  el_after_av_heading  el_before_av_one_half '><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-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-13  el_after_av_hr  el_before_av_one_half  first 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>The aim of a preliminary hazard analysis (PHA) is to identify safety-critical areas at an early stage, deliver initial hazard assessments and define necessary and appropriate hazard controls and subsequent measures. Since it is used both as part of the requirements analysis as well as in the early phases of the design process for your medical device, this provides a relatively early start to risk management in the entire <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304\">lifecycle<\/a> and supports you in identifying risks at an early stage and efficiently considering measures in the development process on this basis.<\/p>\n<p>BAYOOSOFT Risk Manager offers you full integration of the preliminary hazard analysis in the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">basic module<\/a>. Here, you can decide in each of your projects whether you wish to use your previously defined global risk graph templates or customize them in terms of probability of occurrence and the extent of damage.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-14cdc2379ccd0d40ea6e7f35ad8becbd\">\n.flex_column.av-av_one_half-14cdc2379ccd0d40ea6e7f35ad8becbd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-14cdc2379ccd0d40ea6e7f35ad8becbd av_one_half  avia-builder-el-15  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-av_gallery-986b5b6829a7e501a6cad230eede118e\">\n#top .avia-gallery.av-av_gallery-986b5b6829a7e501a6cad230eede118e .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-av_gallery-986b5b6829a7e501a6cad230eede118e avia_animate_when_visible  avia-builder-el-16  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-1'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/\"><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\/2-5-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Risk-Analysis ' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3704 avia-img-lazy-loading-not-3704\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png\" title='2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5.png 1680w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Risk-Analysis <\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5.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\/2-5-1030x644.png' class='first_thumb lightbox ' data-onclick='1' title='Risk-Analysis '  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3704 avia-img-lazy-loading-not-3704\"  data-avia-tooltip='Risk-Analysis ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-845x684.png\" width=\"845\" height=\"684\"  title='2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3704 avia-img-lazy-loading-3704\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png\" title='2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-5.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1030x644.png 1030w, 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fetchpriority=\"high\" class=\"wp-image-3706 avia-img-lazy-loading-not-3706\"  data-avia-tooltip='Revaluation after implementation of measures' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-845x684.png\" width=\"845\" height=\"684\"  title='2-1' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3706 avia-img-lazy-loading-3706\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1030x644.png\" title='2-1' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-1-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2.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\/2-2-2-1030x644.png' class='lightbox ' data-onclick='3' title='Presentation of the distribution of risk after evaluation'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3708 avia-img-lazy-loading-not-3708\"  data-avia-tooltip='Presentation of the distribution of risk after evaluation' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-845x684.png\" width=\"845\" height=\"684\"  title='2-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3708 avia-img-lazy-loading-3708\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1030x644.png\" title='2-2' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-2-2.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/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-2cbf963fb40c64712b92106a92606699\">\n.av-layout-tab.av-av_tab_sub_section-2cbf963fb40c64712b92106a92606699{\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_127004546-1500x1140.jpg);\nbackground-position:center center;\nbackground-repeat:no-repeat;\nbackground-attachment:fixed;\nvertical-align:middle;\n}\n<\/style>\n<div id='av-tab-section-1-2' class='av-layout-tab av-av_tab_sub_section-2cbf963fb40c64712b92106a92606699 av-animation-delay-container  avia-builder-el-17  el_after_av_tab_sub_section  avia-builder-el-last  avia-full-stretch ' data-av-deeplink-tabs=\"\" data-av-tab-section-content=\"2\" data-tab-section-id=\"failure-mode-and-effect-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-av_heading-d3b4cc562014153b438677561510b2ad\">\n#top .av-special-heading.av-av_heading-d3b4cc562014153b438677561510b2ad{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-d3b4cc562014153b438677561510b2ad .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-d3b4cc562014153b438677561510b2ad .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-d3b4cc562014153b438677561510b2ad av-special-heading-h2 blockquote modern-quote  avia-builder-el-18  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Failure Mode and Effect Analysis<\/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_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-19  el_after_av_heading  el_before_av_one_half '><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-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-20  el_after_av_hr  el_before_av_one_half  first 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>Discovering errors in your medical device during the production phase can result in extensive costs to rectify them. For this reason, it is recommended to perform an error analysis already in the early stages of developing your medical device. The method of failure mode and effect analysis (FMEA) enables you to identify any errors at an early stage and thereby avoid them during product development wherever possible.<\/p>\n<p>BAYOOSOFT Risk Manager offers full integration of potential error analysis in the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">basic module<\/a>. Here, you can decide in each of your projects whether you wish to use your previously defined global FMEA catalog templates or customize them in terms of probability of occurrence and discovery. This analysis is then carried out based on the failure type, effect and cause.<\/p>\n<\/div><\/section><\/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-22  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-ki5qkfmw-9899ccdea01d3c9fa50ff637ce8946fd\">\n#top .avia-gallery.av-ki5qkfmw-9899ccdea01d3c9fa50ff637ce8946fd .avia-gallery-thumb a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-ki5qkfmw-9899ccdea01d3c9fa50ff637ce8946fd avia_animate_when_visible  avia-builder-el-23  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\/features\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-768x419.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1536x838.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1500x819.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-705x385.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution.png 1920w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='FMEA distribution of the risk priority number' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6010 avia-img-lazy-loading-not-6010\"  width=\"1030\" height=\"562\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png\" title='FMEA - RNB Distribution' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-768x419.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1536x838.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1500x819.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-705x385.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution.png 1920w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>FMEA distribution of the risk priority number<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-768x419.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1536x838.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1500x819.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-705x385.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution.png 1920w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-2' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png' class='first_thumb lightbox ' data-onclick='1' title='FMEA distribution of the risk priority number'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6010 avia-img-lazy-loading-not-6010\"  data-avia-tooltip='FMEA distribution of the risk priority number' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-845x684.png\" width=\"845\" height=\"684\"  title='FMEA - RNB Distribution' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6010 avia-img-lazy-loading-6010\"  width=\"1030\" height=\"562\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png\" title='FMEA - RNB Distribution' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1030x562.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-768x419.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1536x838.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-1500x819.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution-705x385.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-RNB-Distribution.png 1920w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1030x561.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1030x561.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-300x163.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-768x418.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1536x837.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1500x817.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-705x384.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview.png 1920w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-2' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1030x561.png' class='lightbox ' data-onclick='2' title='FMEA before\/after comparison of the RPN distribution'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6006 avia-img-lazy-loading-not-6006\"  data-avia-tooltip='FMEA before\/after comparison of the RPN distribution' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-845x684.png\" width=\"845\" height=\"684\"  title='FMEA - Before and after Overview' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6006 avia-img-lazy-loading-6006\"  width=\"1030\" height=\"561\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1030x561.png\" title='FMEA - Before and after Overview' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1030x561.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-300x163.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-768x418.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1536x837.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-1500x817.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview-705x384.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Before-and-after-Overview.png 1920w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1030x561.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1030x561.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-300x163.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-768x418.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1536x837.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1500x817.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-705x384.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue.png 1920w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-2' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1030x561.png' class='lightbox ' data-onclick='3' title='Definition of FMEA catalogue templates'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-6008 avia-img-lazy-loading-not-6008\"  data-avia-tooltip='Definition of FMEA catalogue templates' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-845x684.png\" width=\"845\" height=\"684\"  title='FMEA - Define FMEA Catalogue' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-6008 avia-img-lazy-loading-6008\"  width=\"1030\" height=\"561\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1030x561.png\" title='FMEA - Define FMEA Catalogue' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1030x561.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-300x163.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-768x418.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1536x837.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-1500x817.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue-705x384.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/12\/FMEA-Define-FMEA-Catalogue.png 1920w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1030x564.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1030x564.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-768x420.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1536x841.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1500x821.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-705x386.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-450x246.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode.png 1752w\" 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\/fmea-expert-mode-1030x564.png' class='lightbox ' data-onclick='4' title='FMEA expert mode'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3844 avia-img-lazy-loading-not-3844\"  data-avia-tooltip='FMEA expert mode' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-845x684.png\" width=\"845\" height=\"684\"  title='fmea expert mode' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3844 avia-img-lazy-loading-3844\"  width=\"1030\" height=\"564\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1030x564.png\" title='fmea expert mode' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1030x564.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-300x164.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-768x420.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1536x841.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-1500x821.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-705x386.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode-450x246.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/fmea-expert-mode.png 1752w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/div><\/div><\/div><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div id='lifecycle-phase'  class='avia-section av-av_section-9f4299e75f18299d24a23a980c66f6a3 main_color avia-section-default avia-no-shadow  avia-builder-el-24  el_after_av_tab_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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-35be29d23938ee7d0b2860173fa35bb6\">\n#top .av-special-heading.av-av_heading-35be29d23938ee7d0b2860173fa35bb6{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-35be29d23938ee7d0b2860173fa35bb6 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-35be29d23938ee7d0b2860173fa35bb6 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-35be29d23938ee7d0b2860173fa35bb6 av-special-heading-h2 blockquote modern-quote  avia-builder-el-25  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Structured Work According to Lifecycle Phase<\/h2><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>BAYOOSOFT Risk Manager offers you a project and version-based approach for managing your technical documentation. You create projects for your medical devices and can then historicize changes to your risk assessment as well as other module features in versions, depending on the device lifecycle phase or other user-defined steps. By \u201cclosing\u201d various versions, you can ensure that certain versions can no longer be changed retroactively. You then work on subsequent versions.<\/p>\n<\/div><\/section>\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-27  el_after_av_textblock  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The process for preparing risk management documents is structured in accordance with the essential activities of the risk management process as required by the standard. The following processes are distinguished:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-analysis\">Risk analysis<\/a><\/li>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-assessment-\">Risk assessment<\/a><\/li>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-governance\">Risk control<\/a><\/li>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#residual-risk-evaluation\">Reassessment<\/a><\/li>\n<li><a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-monitoring-\">Post-market surveillance<\/a><\/li>\n<\/ul>\n<\/div><\/section><\/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-29  el_after_av_two_fifth  el_before_av_hr  flex_column_div av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-edd7754542610c69d1ed893ade1a3e5d\">\n.avia-image-container.av-av_image-edd7754542610c69d1ed893ade1a3e5d img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-edd7754542610c69d1ed893ade1a3e5d .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-edd7754542610c69d1ed893ade1a3e5d 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-4093 avia-img-lazy-loading-not-4093 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN.png\" alt='' title='Intuitiver Aufbau (EN)'  height=\"826\" width=\"1843\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN.png 1843w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-300x134.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-1030x462.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-768x344.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-1536x688.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-1500x672.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-705x316.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Intuitiver-Aufbau-EN-450x202.png 450w\" sizes=\"(max-width: 1843px) 100vw, 1843px\" \/><\/div><\/div><\/div><\/div>\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-31  el_after_av_three_fifth  el_before_av_textblock '><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>This way, you transparently record the contents and results of your risk management activities and are guided through the process in a structured manner. The automatically generated documents contain your extensive information on your risk management file. The structure of BAYOOSOFT Risk Manager helps you work purposefully and efficiently as you follow the process from top to bottom in the menu tree. BAYOOSOFT Risk Manager thereby accelerates your development and approval process \u2013 allowing you to dedicate your time to the content not the process.<\/p>\n<\/div><\/section>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='mdr-classification'  class='avia-section av-av_section-bda45ee5c610d4592be719368f7eaf9e alternate_color avia-section-default avia-no-shadow  avia-builder-el-33  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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-5b2bda1b45aaf46777a0ee1e05a17884\">\n#top .av-special-heading.av-av_heading-5b2bda1b45aaf46777a0ee1e05a17884{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-5b2bda1b45aaf46777a0ee1e05a17884 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-5b2bda1b45aaf46777a0ee1e05a17884 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-5b2bda1b45aaf46777a0ee1e05a17884 av-special-heading-h2 blockquote modern-quote  avia-builder-el-34  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Medical Device Classification<\/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-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-35  el_after_av_heading  el_before_av_one_half  first 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>Technical documentation is a requirement for the registration or approval of your medical device. Here, the complexity and type of device determines the <strong>risk classification<\/strong> and the scope of necessary documents.<\/p>\n<p>To provide optimal support in classification according to the medical device regulation (MDR Article 51 (1)), we have fully integrated the functionality for <strong>classifying the medical device into categories I, IIa, IIb or III<\/strong> in the validated approval accelerator. Based on an <strong>interactive questionnaire<\/strong>, you are guided through the classification process and can issue the result as a report. This provides you with an initial reference for classifying your medical device. You then only need to give a justification for the classification, considering the intended purpose and stating the applied rules.<\/p>\n<\/div><\/section><\/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-37  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-av_image-0d066029ed666adcc7e219ad23dbd2a9\">\n.avia-image-container.av-av_image-0d066029ed666adcc7e219ad23dbd2a9 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-0d066029ed666adcc7e219ad23dbd2a9 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-0d066029ed666adcc7e219ad23dbd2a9 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-3710 avia-img-lazy-loading-not-3710 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1.png\" alt='' title='MDR-Klassifikator'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/MDR-Klassifikator-1-450x281.png 450w\" sizes=\"(max-width: 1680px) 100vw, 1680px\" \/><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='post-market-surveillance'  class='avia-section av-av_section-f1c0901c953ddd4546a956e7213f272e main_color avia-section-default avia-no-shadow  avia-builder-el-39  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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-341d11d9c7f7d1c400ee9adb6e2f3b6c\">\n#top .av-special-heading.av-av_heading-341d11d9c7f7d1c400ee9adb6e2f3b6c{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-341d11d9c7f7d1c400ee9adb6e2f3b6c .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-341d11d9c7f7d1c400ee9adb6e2f3b6c .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-341d11d9c7f7d1c400ee9adb6e2f3b6c av-special-heading-h2 blockquote modern-quote  avia-builder-el-40  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Post Market Surveillance<\/h2><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>Post-market surveillance refers to a proactive and systematic process for identifying information about medical devices already brought into circulation and for deriving necessary corrective and preventive measures.<\/p>\n<\/div><\/section>\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  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avia-gallery-big-no-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Post Market Surveillance activities' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3712 avia-img-lazy-loading-not-3712\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png\" title='1-13' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-705x441.png 705w, 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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1.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\/1-13-1-1030x644.png' class='first_thumb lightbox ' data-onclick='1' title='Post Market Surveillance activities'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3712 avia-img-lazy-loading-not-3712\"  data-avia-tooltip='Post Market Surveillance activities' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-845x684.png\" width=\"845\" height=\"684\"  title='1-13' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3712 avia-img-lazy-loading-3712\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png\" title='1-13' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-13-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1.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\/2-13-1-1030x644.png' class='lightbox ' data-onclick='2' title='Reminder of Post Market Surveillance activities'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3714 avia-img-lazy-loading-not-3714\"  data-avia-tooltip='Reminder of Post Market Surveillance activities' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-845x684.png\" width=\"845\" height=\"684\"  title='2-13' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-845x684.png 845w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-495x400.png 495w\" sizes=\"(max-width: 845px) 100vw, 845px\" \/><div class='big-prev-fake'><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-3714 avia-img-lazy-loading-3714\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1030x644.png\" title='2-13' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/2-13-1.png 1680w\" sizes=\"auto, (max-width: 1030px) 100vw, 1030px\" \/><\/div><\/a><\/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_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-44  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'     ><section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a manufacturer of medical devices, you are required to define such a systematic process in order to record information about your medical devices or similar products in the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304\">lifecycle phases<\/a> following production. The information collected can be assessed in relation to its potential safety relevance, before defining appropriate measures for minimizing risks associated with your medical device. The aim of the ongoing process is to ensure that your medical devices offer patients the benefits promised and that no unmanageable risks exist.<\/p>\n<p>Thanks to the market monitoring section included in the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">basic module<\/a>, BAYOOSOFT Risk Manager gives you the ability to document your observations. Gathered as part of a ticket system or other system, they can automatically be transferred to BAYOOSOFT Risk Manager \u00a0via the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#rest-api\">REST API<\/a> interface as an extension module for integration into your infrastructure. If during post-market surveillance you determine that a new risk assessment is necessary, this can be suitably proven and documented in this report.<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\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-av_section-cca72454bf7cefd30cf80c4fb8085a58\">\n.avia-section.av-av_section-cca72454bf7cefd30cf80c4fb8085a58{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_142302319-1500x959.jpg);\nbackground-position:100% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id='self-learning-knowledge-database'  class='avia-section av-av_section-cca72454bf7cefd30cf80c4fb8085a58 alternate_color avia-section-default avia-no-shadow  avia-builder-el-46  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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-a63cd199125bab3b979718423c4b0719\">\n#top .av-special-heading.av-av_heading-a63cd199125bab3b979718423c4b0719{\npadding-bottom:10px;\ncolor:#23d3bc;\n}\nbody .av-special-heading.av-av_heading-a63cd199125bab3b979718423c4b0719 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-a63cd199125bab3b979718423c4b0719 .special-heading-inner-border{\nborder-color:#23d3bc;\n}\n.av-special-heading.av-av_heading-a63cd199125bab3b979718423c4b0719 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-a63cd199125bab3b979718423c4b0719 av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-47  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Self-Learning Knowledge Database<\/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-av_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-48  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-av_one_half-7075c5482eebedf7c49de2c5ec0d6381 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-7075c5482eebedf7c49de2c5ec0d6381\">\n.flex_column.av-av_one_half-7075c5482eebedf7c49de2c5ec0d6381{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-7075c5482eebedf7c49de2c5ec0d6381 av_one_half  avia-builder-el-49  el_after_av_hr  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-bottom 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>The intuitive structure of BAYOOSOFT Risk Manager guides you through the process of risk management (in the menu system, from top to bottom). The knowledge developed grows <strong>across projects<\/strong> in the self-learning knowledge database. The information is made available to authorized employees throughout the company. Here, the knowledge database supports your work by providing <strong>frequently recurring elements<\/strong> for preparing a new risk analysis. Groups are used as <strong>suggestion lists<\/strong> for new elements in the risk analysis.<\/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-51  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-bottom av-zero-column-padding  '     ><div  class='avia-button-wrap av-av_button-768411af553476de530d05b4207cb897-wrap avia-button-center  avia-builder-el-52  avia-builder-el-no-sibling '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-av_button-768411af553476de530d05b4207cb897 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 product presentation now\"><span class='avia_iconbox_title' >Arrange a product presentation now<\/span><\/a><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='fine-grained-authorization-management'  class='avia-section av-av_section-e4a49b2582ad348011b1e5d95d45c386 main_color avia-section-default avia-no-shadow  avia-builder-el-53  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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-1e3eca908d09f871af7fbfa54a9565d2\">\n#top .av-special-heading.av-av_heading-1e3eca908d09f871af7fbfa54a9565d2{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-1e3eca908d09f871af7fbfa54a9565d2 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-1e3eca908d09f871af7fbfa54a9565d2 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-1e3eca908d09f871af7fbfa54a9565d2 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\"  >Fine-Grained Authorization Management<\/h2><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>BAYOOSOFT Risk Manager features an auditable, fine-grained authorization system. Users can be created and <strong>roles defined<\/strong> via a central administration interface. When users are assigned to roles, they receive standard authorizations that allow safety concepts to be implemented in projects without further configuration required. Possible authorizations include defining graphs, conducting analyses and assessments, releasing measures and deciding on their implementation and subsequent validation, carrying out reassessment or market monitoring, and recording, validating or verifying measures.<\/p>\n<p>What\u2019s more, each version offers the ability to overwrite the authorizations for each team member <strong>individually<\/strong>. This authorization model allows you to ensure that <strong>only authorized individuals gain access to your data<\/strong> and that auditable evidence is documented for implementation.<\/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-av_section-f74047ee50b98e9a0a929c8bdb1b0eda\">\n.avia-section.av-av_section-f74047ee50b98e9a0a929c8bdb1b0eda{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/09\/shutterstock_524089942-1500x571.jpg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id='greybox'  class='avia-section av-av_section-f74047ee50b98e9a0a929c8bdb1b0eda main_color avia-section-default avia-no-shadow  avia-builder-el-56  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-3197'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-f9fb58e04b53d3d75b8630d5d31a6061\">\n#top .av-special-heading.av-av_heading-f9fb58e04b53d3d75b8630d5d31a6061{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-f9fb58e04b53d3d75b8630d5d31a6061 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-f9fb58e04b53d3d75b8630d5d31a6061 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-f9fb58e04b53d3d75b8630d5d31a6061 av-special-heading-h2 blockquote modern-quote  avia-builder-el-57  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Visualizing with the Grey Box<\/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-av_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-58  el_after_av_heading  el_before_av_one_half '><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-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-59  el_after_av_hr  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-5ccae698e88588e07a935022b1b9099b\">\n.avia-image-container.av-av_image-5ccae698e88588e07a935022b1b9099b img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-5ccae698e88588e07a935022b1b9099b .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-5ccae698e88588e07a935022b1b9099b av-styling- avia-align-center  avia-builder-el-60  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-3716 avia-img-lazy-loading-not-3716 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1.png\" alt='' title='Grey Box'  height=\"1050\" width=\"1680\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1.png 1680w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/Grey-Box-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-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-61  el_after_av_one_half  avia-builder-el-last  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 BAYOOSOFT Risk Manager basic module includes the grey box, offering the function of an <strong>electronic whiteboard<\/strong>. Use it to create process plans, device designs or flow charts, for example. The intuitive graphical editor lets you integrate function dependencies, disturbance variables, inputs and outputs, helping you quickly identify risks and select suitable measures for reducing risk.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-616cd310f4c6bf63bbd1f033802c1165\">\n#top .hr.hr-invisible.av-av_hr-616cd310f4c6bf63bbd1f033802c1165{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-av_hr-616cd310f4c6bf63bbd1f033802c1165 hr-invisible  avia-builder-el-63  el_after_av_textblock  el_before_av_textblock '><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-av_textblock-78c2fee3dd1850cbf3f25941c4390acb\">\n#top .av_textblock_section.av-av_textblock-78c2fee3dd1850cbf3f25941c4390acb .avia_textblock{\ncolor:#373736;\n}\n<\/style>\n<section  class='av_textblock_section av-av_textblock-78c2fee3dd1850cbf3f25941c4390acb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><a href=\"https:\/\/www.riskmanager.net\/en\/services\/test-now\">See for yourself as part of a 30-day trial<\/a>\u00a0\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_font_icon-901b0586732706062c3c3ab6e4298fe9\">\n.av_font_icon.av-av_font_icon-901b0586732706062c3c3ab6e4298fe9{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-av_font_icon-901b0586732706062c3c3ab6e4298fe9 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-av_font_icon-901b0586732706062c3c3ab6e4298fe9 avia_animate_when_visible av-icon-style- avia-icon-pos-left avia-icon-animate'><a href='https:\/\/www.riskmanager.net\/services\/jetzt-testen\/'  target=\"_blank\"  rel=\"noopener noreferrer\"  class='av-icon-char' aria-hidden='false' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' data-avia-icon-tooltip=\"&lt;br \/&gt;\nJetzt TRIAL anfordern&lt;br \/&gt;\n\"><\/a><\/span><\/p>\n<\/div><\/section><\/p><\/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-av_section-6a123ca33aaac4ac55e5dbaa7cc6cfa9\">\n.avia-section.av-av_section-6a123ca33aaac4ac55e5dbaa7cc6cfa9{\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-av_section-6a123ca33aaac4ac55e5dbaa7cc6cfa9 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_9'  class='avia-section av-av_section-6a123ca33aaac4ac55e5dbaa7cc6cfa9 main_color avia-section-default avia-no-shadow  avia-builder-el-66  el_after_av_section  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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-av_button-9235b418cc689912f84262269b2f773b-wrap avia-button-center  avia-builder-el-69  el_after_av_icon_box  el_before_av_icon_box '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact'  class='avia-button av-av_button-9235b418cc689912f84262269b2f773b 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-av_icon_box-754db96e0e107423adb1754172045bda\">\n.iconbox.av-av_icon_box-754db96e0e107423adb1754172045bda .iconbox_icon{\nbackground-color:#23d3bc;\nborder:1px solid #23d3bc;\ncolor:#000000;\n}\n#top #wrap_all .iconbox.av-av_icon_box-754db96e0e107423adb1754172045bda .iconbox_content_title{\ncolor:#23d3bc;\n}\n.iconbox.av-av_icon_box-754db96e0e107423adb1754172045bda .iconbox_content_container{\ncolor:#ffffff;\n}\n<\/style>\n<article  class='iconbox iconbox_left_content av-av_icon_box-754db96e0e107423adb1754172045bda  avia-builder-el-70  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-av_button-4a78d865dd0f225d6bbfd10f9f6c411b-wrap avia-button-center  avia-builder-el-71  el_after_av_icon_box  el_before_av_hr '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now'  class='avia-button av-av_button-4a78d865dd0f225d6bbfd10f9f6c411b 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-av_hr-bbe676ee29fcde2ee286114023beb888\">\n#top .hr.hr-invisible.av-av_hr-bbe676ee29fcde2ee286114023beb888{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-av_hr-bbe676ee29fcde2ee286114023beb888 hr-invisible  avia-builder-el-72  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":8795,"parent":3090,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3197","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3197","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=3197"}],"version-history":[{"count":17,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3197\/revisions"}],"predecessor-version":[{"id":8877,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3197\/revisions\/8877"}],"up":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3090"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/8795"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=3197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}