{"id":10035,"date":"2022-06-08T16:42:32","date_gmt":"2022-06-08T14:42:32","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=10035"},"modified":"2022-06-10T09:08:50","modified_gmt":"2022-06-10T07:08:50","slug":"risk-management-in-the-development","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/06\/08\/risk-management-in-the-development\/","title":{"rendered":"Risk management in the development process of medical devices: Beginning and end?"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f3aw9n-f901405eb7fa955dcf0c51424d2d62b3\">\n.avia-section.av-f3aw9n-f901405eb7fa955dcf0c51424d2d62b3{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/06\/Header-RM.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-f3aw9n-f901405eb7fa955dcf0c51424d2d62b3 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-f3aw9n-f901405eb7fa955dcf0c51424d2d62b3 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='600'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:600px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10035'><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-vc96j-73e56fe94a849d655dc1094b25ecdf20 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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48\">\n.flex_column.av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48 av_one_fifth  avia-builder-el-2  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-76oet7-63ca99088c885b6e5ffde33022dbe4da\">\n.flex_column.av-76oet7-63ca99088c885b6e5ffde33022dbe4da{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-76oet7-63ca99088c885b6e5ffde33022dbe4da av_three_fifth  avia-builder-el-3  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l45npr4k-844b342569bcedeb4910bdabb08973e5\">\n#top .av-special-heading.av-l45npr4k-844b342569bcedeb4910bdabb08973e5{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l45npr4k-844b342569bcedeb4910bdabb08973e5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l45npr4k-844b342569bcedeb4910bdabb08973e5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l45npr4k-844b342569bcedeb4910bdabb08973e5 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-4  el_before_av_hr  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Risk management in the development process of medical devices: Beginning and end?<\/h1><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-l324tmrf-fe85b91b6f816db2d08112a16e73079e\">\n#top .hr.hr-invisible.av-l324tmrf-fe85b91b6f816db2d08112a16e73079e{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l324tmrf-fe85b91b6f816db2d08112a16e73079e hr-invisible  avia-builder-el-5  el_after_av_heading  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-l30a8pco-d9e112ec483b6c18d37d0137b556536e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Only when a medical device has been fully developed and is ready for market launch should manufacturers concern themselves with risk management. Right? Wrong! Risk management is an essential requirement for every medical device &#8211; before development, during the process, at market launch and beyond. Which steps in the development process are central and what you should consider in the risk analysis according to EN ISO 14971 &#8211; we describe it to you.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l324tmrf-fe85b91b6f816db2d08112a16e73079e\">\n#top .hr.hr-invisible.av-l324tmrf-fe85b91b6f816db2d08112a16e73079e{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l324tmrf-fe85b91b6f816db2d08112a16e73079e hr-invisible  avia-builder-el-7  el_after_av_textblock  el_before_av_icon_box '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<article  class='iconbox iconbox_top av-l30ace0e-92b04424743702359c17547696dbe8a0  avia-builder-el-8  el_after_av_hr  avia-builder-el-last  main_color'  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='\ue864' 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>The EU standard ISO 14971 is central to the risk management of medical devices. It describes the application of risk management to medical devices and thus a process to ensure that risks are known, controllable and acceptable compared to the benefits.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b\">\n.flex_column.av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b av_one_fifth  avia-builder-el-9  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/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-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-10  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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a\">\n.flex_column.av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a av_four_fifth  avia-builder-el-11  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-l45oanm6-f1f562f8dced2e8bf9d9bf5d16416bbd\">\n#top .av-special-heading.av-l45oanm6-f1f562f8dced2e8bf9d9bf5d16416bbd{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l45oanm6-f1f562f8dced2e8bf9d9bf5d16416bbd .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l45oanm6-f1f562f8dced2e8bf9d9bf5d16416bbd .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l45oanm6-f1f562f8dced2e8bf9d9bf5d16416bbd av-special-heading-h2 blockquote modern-quote  avia-builder-el-12  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >From the idea to placing on the market: The most important steps in the development of medical devices<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>First and foremost is the awareness of risk management. Manufacturers should prioritise and document this process from the beginning. ISO 14971 describes exactly how the risk management process should be set up. According to this, the process must include the following points:<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l324tmrf-fe85b91b6f816db2d08112a16e73079e\">\n#top .hr.hr-invisible.av-l324tmrf-fe85b91b6f816db2d08112a16e73079e{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l324tmrf-fe85b91b6f816db2d08112a16e73079e hr-invisible  avia-builder-el-14  el_after_av_textblock  el_before_av_iconlist '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-icon-list-container av-l44baka6-3fab099e5be6f5c93592b7d85914bae9  avia-builder-el-15  el_after_av_hr  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l44baka6-3fab099e5be6f5c93592b7d85914bae9 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-3575w2b-de33340bb26f082a10afe049d65980b0 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk analysis\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk analysis<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Identify hazards, probabilities, severities and risks, decide on the acceptability of the risks.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-8q2dcj-740cce21cbc2ed9cc0971c8b1cb1d33d avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue855' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk assessment\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk assessment<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Determine measures to minimise risks, analyse new risks on the basis of this (decide again on the justifiability of the risks).<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-28quzoz-fbd4f23716e4d259c765fdf30503e298 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue849' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk governance\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk governance<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>The central component of the technical documentation is the measures taken<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1n48ar7-7fb2be4f03bbac4afb6487805d63c9b3 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8c5' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Residual risk evaluation\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Residual risk evaluation<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>the re-evaluation provides information about new risks<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-10c7z9v-767d4cc2a7e01943e8cad08f36bf7717 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk monitoring\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Risk monitoring<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>In the form of post-market surveillance<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-afq4r-708003752ba960f04e49bf1cb7fa335f main_color avia-section-default avia-no-border-styling  avia-builder-el-16  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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_three_fifth  avia-builder-el-17  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-bd166bd47cb7e042e28be3676337f051\">\n#top .av-special-heading.av-av_heading-bd166bd47cb7e042e28be3676337f051{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-bd166bd47cb7e042e28be3676337f051 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-bd166bd47cb7e042e28be3676337f051 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-bd166bd47cb7e042e28be3676337f051 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\"  >The beginning: product optimisation through risk 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-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-19  el_after_av_heading  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-3b2aa58bf488bb866a0aecd278116c27\">\n.flex_column.av-2bgywr-3b2aa58bf488bb866a0aecd278116c27{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-3b2aa58bf488bb866a0aecd278116c27 av_two_fifth  avia-builder-el-20  el_after_av_three_fifth  el_before_av_three_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_three_fifth  avia-builder-el-21  el_after_av_two_fifth  el_before_av_two_fifth  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The focus of risk management for medical devices is undoubtedly on the safety and health of patients and users. Every development therefore begins with a comprehensive analysis of possible risks, even before the first prototype is ready for demonstration. However, a well-documented risk analysis is not only indispensable for avoiding possible dangers for patients and users.<\/p>\n<p>Identifying errors or unfeasible processes in production at an early stage optimises the product, saves time and thus reduces possible modification costs for manufacturers. It is important that the analysis covers the entire life cycle of the medical device and identifies all risks associated with use, maintenance and disposal. Only if all possible risks are prepared and documented in detail can a standard-compliant assessment of the risks be made.<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Two procedures have become widely established for risk analysis: Preliminary Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA). While PHA follows the &#8220;top-down&#8221; principle as an approach &#8211; i.e. it becomes more and more specific from the general &#8211; FMEA uses a &#8220;button-up&#8221; method and works its way from the concrete to the general.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-3b2aa58bf488bb866a0aecd278116c27\">\n.flex_column.av-2bgywr-3b2aa58bf488bb866a0aecd278116c27{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-3b2aa58bf488bb866a0aecd278116c27 av_two_fifth  avia-builder-el-24  el_after_av_three_fifth  el_before_av_hr  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3251g6b-c5128536ef9824ad142f1b2e65bc4e7d\">\n#top .hr.hr-invisible.av-l3251g6b-c5128536ef9824ad142f1b2e65bc4e7d{\nheight:20px;\n}\n<\/style>\n<div  class='hr 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https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/01\/Riskmanager_banner-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/01\/Riskmanager_banner-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/01\/Riskmanager_banner-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725\">\n#top .hr.hr-invisible.av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725 hr-invisible  avia-builder-el-27  el_after_av_two_fifth  el_before_av_one_fifth '><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-2bgywr-907b9fb9f5c880948ee416dae52e96ba\">\n.flex_column.av-2bgywr-907b9fb9f5c880948ee416dae52e96ba{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-907b9fb9f5c880948ee416dae52e96ba av_one_fifth  avia-builder-el-28  el_after_av_hr  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-ed580c12b4bf0ff292a78251c959e392\">\n@keyframes av_boxShadowEffect_av-3kietn-ed580c12b4bf0ff292a78251c959e392-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-3kietn-ed580c12b4bf0ff292a78251c959e392{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:1px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:12px 12px 12px 12px;\npadding:15px 15px 15px 15px;\nbackground-color:#99c1bc;\n}\n<\/style>\n<div  class='flex_column av-3kietn-ed580c12b4bf0ff292a78251c959e392 av_three_fifth  avia-builder-el-29  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30a9f68-65fce345849e55be7cc6a624f3526837\">\n#top .av_textblock_section.av-l30a9f68-65fce345849e55be7cc6a624f3526837 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-l30a9f68-65fce345849e55be7cc6a624f3526837 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center\"><strong>More differences?\u00a0<\/strong><\/p>\n<p style=\"text-align: center\"><strong>Read more about it now in our blog.<\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725\">\n#top .hr.hr-invisible.av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725 hr-invisible  avia-builder-el-31  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-l30aw29k-01bbbc82e6237bf11590ae0cb46cf2e2-wrap avia-button-center  avia-builder-el-32  el_after_av_hr  avia-builder-el-last '><a href=''  class='avia-button av-l30aw29k-01bbbc82e6237bf11590ae0cb46cf2e2 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Blog\"><span class='avia_iconbox_title' >Blog<\/span><\/a><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-3b2aa58bf488bb866a0aecd278116c27\">\n.flex_column.av-2bgywr-3b2aa58bf488bb866a0aecd278116c27{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-3b2aa58bf488bb866a0aecd278116c27 av_one_fifth  avia-builder-el-33  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-34  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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_three_fifth  avia-builder-el-35  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l45p2a9w-1ecec9387ec459324578d53fb7a3558c\">\n#top .av-special-heading.av-l45p2a9w-1ecec9387ec459324578d53fb7a3558c{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l45p2a9w-1ecec9387ec459324578d53fb7a3558c .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l45p2a9w-1ecec9387ec459324578d53fb7a3558c .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l45p2a9w-1ecec9387ec459324578d53fb7a3558c av-special-heading-h2 blockquote modern-quote  avia-builder-el-36  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >The end: When is the risk management process complete? <\/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-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-37  el_after_av_heading  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-3b2aa58bf488bb866a0aecd278116c27\">\n.flex_column.av-2bgywr-3b2aa58bf488bb866a0aecd278116c27{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-3b2aa58bf488bb866a0aecd278116c27 av_two_fifth  avia-builder-el-38  el_after_av_three_fifth  el_before_av_four_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_four_fifth  avia-builder-el-39  el_after_av_two_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>One certainty remains in the development of medical devices: Risk management is not static and therefore never complete. ISO 14971 requires post-market surveillance &#8211; and this always brings to light new results and findings about the medical device. The documentation effort for manufacturers therefore remains even after the product has been placed on the market.<\/p>\n<\/div><\/section><\/div>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_6'  class='avia-section av-27n5hn-c7cc5b4db77dfca597f3eb4f2c4d452b main_color avia-section-default avia-no-border-styling  avia-builder-el-41  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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_one_fifth  avia-builder-el-42  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_three_fifth  avia-builder-el-43  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s0idcj-b0e090a7e4e3b57a89b6aa39dd3f7f31\">\n#top .av-special-heading.av-s0idcj-b0e090a7e4e3b57a89b6aa39dd3f7f31{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-s0idcj-b0e090a7e4e3b57a89b6aa39dd3f7f31 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-s0idcj-b0e090a7e4e3b57a89b6aa39dd3f7f31 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-s0idcj-b0e090a7e4e3b57a89b6aa39dd3f7f31 av-special-heading-h2 blockquote modern-quote  avia-builder-el-44  avia-builder-el-no-sibling '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >The efficient way to technical documentation<\/h2><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-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_one_fifth  avia-builder-el-45  el_after_av_three_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_one_fifth  avia-builder-el-46  el_after_av_one_fifth  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_three_fifth  avia-builder-el-47  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><p><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>How can the risk management process be simplified for manufacturers of medical devices? The BAYOOSOFT Risk Manager supports you as the world&#8217;s leading software solution. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner. In this way, you avoid redundant data storage. Reports are generated with the most up-to-date data at the touch of a button.<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>There are some special features to consider in the risk management of medical software. IEC 62304 applies here for the development and maintenance of medical device software. Read <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304\" target=\"_blank\" rel=\"noopener\">here<\/a> how you as a manufacturer can implement the regulatory requirements, avoid unnecessary effort and achieve conformity.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-50  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-l30aw29k-570302a9b8fe6406afb5ceb9de5c3d97-wrap avia-button-center  avia-builder-el-51  el_after_av_hr  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304'  class='avia-button av-l30aw29k-570302a9b8fe6406afb5ceb9de5c3d97 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"get to know more\"><span class='avia_iconbox_title' >get to know more<\/span><\/a><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_one_fifth  avia-builder-el-52  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><\/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-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_7'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-53  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-10035'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5lt33v-d63609e58a69f1b968e641a03da4916f\">\n.flex_column.av-5lt33v-d63609e58a69f1b968e641a03da4916f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5lt33v-d63609e58a69f1b968e641a03da4916f av_one_fifth  avia-builder-el-54  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4q896j-986c4534337738df611a2a9d356d3194\">\n.flex_column.av-4q896j-986c4534337738df611a2a9d356d3194{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4q896j-986c4534337738df611a2a9d356d3194 av_three_fifth  avia-builder-el-55  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><div  class='av-social-sharing-box av-l325cw4w-53f7c3a545d8488ff7e7d9b6c79a2410 av-social-sharing-box-minimal  avia-builder-el-56  avia-builder-el-no-sibling  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds interesting? 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