{"id":7480,"date":"2021-07-28T09:47:58","date_gmt":"2021-07-28T07:47:58","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=7480"},"modified":"2021-10-15T10:48:03","modified_gmt":"2021-10-15T08:48:03","slug":"software-development-according-to-iec-62304-which-requirements-do-you-have-to-fulfil","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2021\/07\/28\/software-development-according-to-iec-62304-which-requirements-do-you-have-to-fulfil\/","title":{"rendered":"Software development according to IEC 62304: Which requirements do you have to fulfil?"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-2922f13ab9448e178c1fc12e01d07d24\">\n.avia-section.av-kkwbho9e-2922f13ab9448e178c1fc12e01d07d24{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/06\/shutterstock_1767864776.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-kkwbho9e-2922f13ab9448e178c1fc12e01d07d24 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-2922f13ab9448e178c1fc12e01d07d24 main_color avia-section-default 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 av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7480'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-bjkpou-4d21ae85a694f724a081997bbbff889f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  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-7480'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r4r66-90380a229f4631b5c0d2990376471ae0\">\n.flex_column.av-9r4r66-90380a229f4631b5c0d2990376471ae0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9r4r66-90380a229f4631b5c0d2990376471ae0 av_four_fifth  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4gr73s-ae72a7f9980db2c8213e849c0e500108\">\n#top .av-special-heading.av-4gr73s-ae72a7f9980db2c8213e849c0e500108{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-4gr73s-ae72a7f9980db2c8213e849c0e500108 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-4gr73s-ae72a7f9980db2c8213e849c0e500108 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-4gr73s-ae72a7f9980db2c8213e849c0e500108 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Software development according to IEC 62304: Which requirements do you have to fulfil?<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-4  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>IEC 62304 is an international standard that sets minimum requirements for the most important processes of the software life cycle. It applies both to manufacturers who develop their software as an independent medical device (standalone software) and to those who merely embed software in their medical device (embedded software).<\/p>\n<p>Based on DIN EN ISO 14971, the standard also describes the role of risk management within the software development process. Specifically, IEC 62304 defines requirements for the following processes of the software life cycle:<\/p>\n<ul>\n<li>Software development<\/li>\n<li>Software maintenance<\/li>\n<li>Software risk management<\/li>\n<li>Software Configuration Management<\/li>\n<li>Software problem solving<\/li>\n<\/ul>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In addition to the specific requirements for the various processes, IEC 62304 requires the use of a quality management system, a risk management system and a software safety classification.<\/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-6ypsa6-af563f85c4bb555d5a6ad58ed8534a69\">\n.avia-section.av-6ypsa6-af563f85c4bb555d5a6ad58ed8534a69{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/09\/shutterstock_516454909.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-af563f85c4bb555d5a6ad58ed8534a69 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-af563f85c4bb555d5a6ad58ed8534a69 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7480'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-8  el_before_av_one_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kqj3fzs5-61924bd973b6f25b2f66447075a966af\">\n#top .av-special-heading.av-kqj3fzs5-61924bd973b6f25b2f66447075a966af{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kqj3fzs5-61924bd973b6f25b2f66447075a966af .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kqj3fzs5-61924bd973b6f25b2f66447075a966af .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kqj3fzs5-61924bd973b6f25b2f66447075a966af av-special-heading-h3 blockquote modern-quote  avia-builder-el-9  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Safety classification according to IEC 62304<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kq9k1iff-30180044fdd3575dfb8c24e01dba568c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The safety classification allows manufacturers of medical devices to adjust the effort required for the documentation of their software. The higher the potential damage caused by a software error, the more effort they have to put into documenting their software development.<\/p>\n<p>IEC 62304 distinguishes between safety classes A, B and C, whereby the most effort must be made for safety class C. The safety classes are defined as follows:<\/p>\n<\/div><\/section><br \/>\n<div  class='togglecontainer av-kqicfyjp-a81d1611baa8a1e888929b926a1dbfbc  avia-builder-el-11  el_after_av_textblock  avia-builder-el-last ' >\n<section class='av_toggle_section av-bulvuw-2f81152ab05abee55e39fe4f187401d8'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  activeTitle av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"Safety class A\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Safety class A\" data-aria_expanded=\"Click to collapse: Safety class A\">Safety class A<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  active_tc av-title-above' style='display:block;' ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>For safety class A, a software error <strong>must not cause injury or damage to health<\/strong>. However, there is an exception to this: software systems also fall into class A if an error can lead to a situation that endangers health, but the risk is acceptable &#8211; at the latest when risk control measures are initiated. However, these measures may only be outside the software.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-avhqlk-b7fadb49f8ff5b7792fdcbcba08ecb6e'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"Safety class B\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Safety class B\" data-aria_expanded=\"Click to collapse: Safety class B\">Safety class B<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><strong>No severe damage<\/strong> must be possible through software systems that fall into class B. In concrete terms, this means that a software error may lead to an unacceptable risk, but according to the risk control measures, it must not result in severe damage.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-9ubfl4-fd9db0a23cbebec1990089c3c374bfb6'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"Safety class C\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Safety class C\" data-aria_expanded=\"Click to collapse: Safety class C\">Safety class C<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>For software systems classified as Class C, a software error can lead to <strong>serious injury or even death<\/strong>.<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-85b3d8d408f80152e13fe296657fc778\">\n.flex_column.av-bcmscg-85b3d8d408f80152e13fe296657fc778{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-85b3d8d408f80152e13fe296657fc778 av_one_fourth  avia-builder-el-12  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-6ypsa6-98695f771d14b674197121c82d95ada8 main_color avia-section-default avia-no-border-styling  avia-builder-el-13  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-7480'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-14  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kqj3koza-2d7768a3df4cc0d62bd5ffaeaaac664d\">\n#top .av-special-heading.av-kqj3koza-2d7768a3df4cc0d62bd5ffaeaaac664d{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kqj3koza-2d7768a3df4cc0d62bd5ffaeaaac664d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kqj3koza-2d7768a3df4cc0d62bd5ffaeaaac664d .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kqj3koza-2d7768a3df4cc0d62bd5ffaeaaac664d av-special-heading-h3 blockquote modern-quote  avia-builder-el-15  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Requirements for software development according to IEC 62304<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Depending on the security class of the software, a different number of requirements must be met for the documentation of the software development:<\/p>\n<ul>\n<li>Software development plan (A, B, C)<\/li>\n<li>Software requirements analysis (A, B, C)<\/li>\n<li>Software architecture design (B, C)<\/li>\n<li>Software design creation (C)<\/li>\n<li>Implementation and verification of software units (B, C)<\/li>\n<li>Software integration and integration testing (B, C)<\/li>\n<li>Software system test (B, C)<\/li>\n<li>Software release (A, B, C)<\/li>\n<\/ul>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In a software system, the security class of the individual components may well be assessed differently. Since a different number of the above-mentioned requirements have to be fulfilled depending on the security class, it makes a lot of sense to integrate functions with a high and functions with a low security class into different components.<\/p>\n<p>Of course, it must be ensured that the risks are actually limited to the corresponding components.<\/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-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e\">\n.avia-section.av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/10\/shutterstock_270633650-min-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:5px;\nmargin-bottom:0px;\n}\n.avia-section.av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e .av-section-color-overlay{\nopacity:0.8;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e alternate_color avia-section-default avia-no-border-styling  avia-builder-el-18  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7480'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-19  el_before_av_three_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-5f89a415dc4dce34b1b1ee5417fa139f\">\n#top .av-special-heading.av-av_heading-5f89a415dc4dce34b1b1ee5417fa139f{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-5f89a415dc4dce34b1b1ee5417fa139f .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-5f89a415dc4dce34b1b1ee5417fa139f .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-5f89a415dc4dce34b1b1ee5417fa139f av-special-heading-h3 blockquote modern-quote  avia-builder-el-20  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Risk management according to ISO 62304<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The entire risk management process is also subject to certain requirements according to IEC 62304:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-kqicw8sk-43910884f64986f93ec78b6cefec00d4  avia-builder-el-22  el_after_av_textblock  el_before_av_textblock '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-kqicw8sk-43910884f64986f93ec78b6cefec00d4 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-88tdzc-83790bbb1051697a14e93fddc85d1346 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue803' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Analysis of the hazard situation\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Analysis of the hazard situation<\/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-56hc5k-85ee9c15bc9127baad151da35d464d85 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue826' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk control measures\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk control measures<\/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-4c6dgo-06f89349671893b8f25114d27964bedc avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue83f' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Verification of risk control measures\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Verification of risk control measures<\/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-285big-b48121635050dab6f70842ba43a01ded avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8df' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk management of changes in the software\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk management of changes in the software<\/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><br \/>\n<section  class='av_textblock_section av-kq9jv3fi-c04d56677bd1a566f449e3caa401bd18 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The norm requires that risk analysis be integrated into the entire development process. Whether all normative requirements have been met can be determined by inspecting the entire documentation. This also includes the risk management file.<\/p>\n<p>The BAYOOSOFT Risk Manager offers a solution for the documentation of software development that is compliant with IEC 62304. International laws and regulations, EU directives, FDA guidelines, product and process standards, guidance documents and quality management systems form the basis of the Risk Manager.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2hdytk-2cf4e6c559ac24c8da0ab9ce5c7d1b0e\">\n.flex_column.av-2hdytk-2cf4e6c559ac24c8da0ab9ce5c7d1b0e{\nborder-width:2px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:0px 0px 0px 0px;\npadding:20px 20px 20px 20px;\n}\n<\/style>\n<div  class='flex_column av-2hdytk-2cf4e6c559ac24c8da0ab9ce5c7d1b0e av_three_fourth  avia-builder-el-24  el_after_av_three_fourth  avia-builder-el-last  first flex_column_div  column-top-margin'     ><article  class='iconbox iconbox_left av-kqj4e9xq-e651a59efac74897f9d218e313dda3ba  avia-builder-el-25  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Good to know\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue81f' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Good to know<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>Traceability matrices can be used to prove that the development of medical device software conforms to IEC 62304.<\/p>\n<p>These ensure that customer requirements have been checked within the framework of suitable validation processes and that they have been incorporated into the software and verified against the requirements &#8211; a demanding task, especially for large systems.<\/p>\n<p>As a standard-compliant solution, the BAYOOSOFT Risk Manager combines the extension modules <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#requirements-engineering-traceability\" target=\"_blank\" rel=\"noopener\">Requirements Engineering<\/a> and <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#rest-api\" target=\"_blank\" rel=\"noopener\">REST API<\/a> with risk management according to ISO 14971.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_6'  class='avia-section av-2uan7g-c1b018ca26da418793c3f2e314294a46 main_color avia-section-default avia-no-border-styling  avia-builder-el-26  el_after_av_section  avia-builder-el-last  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-7480'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-313788-28b9de3b08c4d31559ae637bd9a96f0b\">\n.flex_column.av-313788-28b9de3b08c4d31559ae637bd9a96f0b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-313788-28b9de3b08c4d31559ae637bd9a96f0b av_three_fourth  avia-builder-el-27  el_before_av_hr  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><div  class='av_promobox av-kp6yhpxv-5b1f749a2c21626f9dd924c41c496e1f avia-button-yes  avia-builder-el-28  avia-builder-el-no-sibling '><div class='avia-promocontent'><p>\nMake an appointment today for an individual product presentation. Our risk management experts will be happy to give you a detailed presentation of the BAYOOSOFT Risk Manager.<\/p>\n<\/div><div  class='avia-button-wrap av-kp6yhpxv-c1f2ea063a9fcbf0dd6c64d30fa5827f-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact\/'  class='avia-button av-kp6yhpxv-c1f2ea063a9fcbf0dd6c64d30fa5827f av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'   aria-label=\"inquiry\"><span class='avia_iconbox_title' >inquiry<\/span><\/a><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kqku6qqs-0ea1188e2967d7b86609c234a3017a34\">\n#top .hr.hr-invisible.av-kqku6qqs-0ea1188e2967d7b86609c234a3017a34{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-kqku6qqs-0ea1188e2967d7b86609c234a3017a34 hr-invisible  avia-builder-el-29  el_after_av_three_fourth  el_before_av_codeblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":42,"featured_media":7472,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[],"class_list":["post-7480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-editorial-en"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7480","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=7480"}],"version-history":[{"count":9,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7480\/revisions"}],"predecessor-version":[{"id":11716,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7480\/revisions\/11716"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/7472"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=7480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/categories?post=7480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/tags?post=7480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}