{"id":7098,"date":"2021-04-28T15:09:37","date_gmt":"2021-04-28T13:09:37","guid":{"rendered":"https:\/\/www.riskmanager.net\/2021\/04\/28\/ende-der-mdr-uebergangsfrist-2017-745-wie-sie-die-zeit-effektiv-nutzen-koennen\/"},"modified":"2021-04-29T16:00:55","modified_gmt":"2021-04-29T14:00:55","slug":"ende-der-mdr-uebergangsfrist-2017-745-wie-sie-die-zeit-effektiv-nutzen-koennen","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2021\/04\/28\/ende-der-mdr-uebergangsfrist-2017-745-wie-sie-die-zeit-effektiv-nutzen-koennen\/","title":{"rendered":"End of the MDR deadline 2017\/745: How to use the time effectively"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-182e5d1e93fd45a2fa26ad06359f66d6\">\n.avia-section.av-kkwbho9e-182e5d1e93fd45a2fa26ad06359f66d6{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-kkwbho9e-182e5d1e93fd45a2fa26ad06359f66d6 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#ebebeb;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-182e5d1e93fd45a2fa26ad06359f66d6 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-7098'><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-7098'><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_one_full  avia-builder-el-2  el_before_av_one_full  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-ko2if3kq-3a4cba83034d515a2117054758cbf3ec\">\n#top .av-special-heading.av-ko2if3kq-3a4cba83034d515a2117054758cbf3ec{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ko2if3kq-3a4cba83034d515a2117054758cbf3ec .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ko2if3kq-3a4cba83034d515a2117054758cbf3ec .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ko2if3kq-3a4cba83034d515a2117054758cbf3ec av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >End of the MDR deadline 2017\/745: How to use the time effectively<\/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_one_full  avia-builder-el-4  el_after_av_one_full  el_before_av_four_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">One year later than originally scheduled, the transitional period of the European Medical Devices Regulation 2017\/745 now ends on 25 May 2021. Due to the Corona pandemic, manufacturers have been granted an additional year to adapt their medical devices to the regulatory requirements. How to use the remaining time effectively and what to consider:<\/p>\n<h3><strong>An overview.<\/strong><\/h3>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-87yq9a-97471933d78f027cf5aab13426fdf11f\">\n.flex_column.av-87yq9a-97471933d78f027cf5aab13426fdf11f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-87yq9a-97471933d78f027cf5aab13426fdf11f av_four_fifth  avia-builder-el-6  el_after_av_one_full  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='avia-icon-list-container av-ko18l7lx-fddf905b46c0fe2ef0d21732a9f16ef3  avia-builder-el-7  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-ko18l7lx-fddf905b46c0fe2ef0d21732a9f16ef3 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-6lle56-6f3b9e5d2a99f840afebe7bbda2b78f2 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue81f' 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: Technical documentation\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Technical documentation<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>According to MDR 2017\/745 more central than ever: The technical documentation contains all relevant information and documents of a medical device and is a prerequisite for its approval. The specific structure of the document is specified in even greater detail by the MDR. Also new is the role of a responsible person who is committed to the preparation and monitoring of the EU declaration of conformity and technical documentation.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-4yeowa-e4128469bcb48c137bf5b8583562c9f9 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: After placing on the market\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >After placing on the market<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Also specified by the MDR: The technical documentation must also be updated after the product has been placed on the market. The storage period of the files is at least ten years for medical devices and 15 years for implants.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-7t57u-02c3ed95a38e2a5ebd017dc3b90f10c7 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: Error prevention\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Error prevention<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>This makes it all the more crucial for manufacturers to have structured work processes in order to avoid errors in the preparation of the technical documentation right from the start. Time and resource constraints before the end of the transition period should not affect this. Software systems validated according to ISO 13485 offer solutions, because they guarantee structure in audit-proof environments.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6ypsa6-d2627cd27a8d374f4033582c323d42ae\">\n.avia-section.av-6ypsa6-d2627cd27a8d374f4033582c323d42ae{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-scaled.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-d2627cd27a8d374f4033582c323d42ae .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-d2627cd27a8d374f4033582c323d42ae alternate_color avia-section-default avia-no-border-styling  avia-builder-el-8  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-7098'><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_four_fifth  avia-builder-el-9  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-ko2iimrj-83553d2ebe8909918adec763d8d27aa0\">\n#top .av-special-heading.av-ko2iimrj-83553d2ebe8909918adec763d8d27aa0{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ko2iimrj-83553d2ebe8909918adec763d8d27aa0 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ko2iimrj-83553d2ebe8909918adec763d8d27aa0 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ko2iimrj-83553d2ebe8909918adec763d8d27aa0 av-special-heading-h2 blockquote modern-quote  avia-builder-el-10  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Structure instead of document jungle<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><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>The regulatory requirements of MDR 2017\/745 are extensive and growing. Preparing the results of different processes in consideration of the regulatory requirements is quite complex &#8211; and prone to errors. Especially the obligation to update and document according to MDR, which covers the entire product life cycle, complicates decentralised working methods.<\/p>\n<p>Validated software solutions such as the BAYOOSOFT Risk Manager create the advantage here. The authorisation accelerator makes it possible to record all relevant information in a clearly structured environment. This information is stored centrally in an audit-proof manner and dynamically linked in a fine-granular manner &#8211; automated up-to-dateness at the push of a button.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-3meicu-d8495e3eb4ff49e05084cd0b2b2ee015 main_color avia-section-default avia-no-border-styling  avia-builder-el-12  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-7098'><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_four_fifth  avia-builder-el-13  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-ko2ijgqn-0887e9bb5610129275d0559400482f39\">\n#top .av-special-heading.av-ko2ijgqn-0887e9bb5610129275d0559400482f39{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ko2ijgqn-0887e9bb5610129275d0559400482f39 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ko2ijgqn-0887e9bb5610129275d0559400482f39 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ko2ijgqn-0887e9bb5610129275d0559400482f39 av-special-heading-h2 blockquote modern-quote  avia-builder-el-14  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >The time factor: software solution as approval accelerator?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><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>Medical device manufacturers have only a few weeks left until the end of the transition period. In addition to a structured methodology for the preparation of technical documentation, they can make optimal use of the remaining time.<\/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-kkwbkig3-9a5131f514651ad406056abe74c531f0\">\n.avia-section.av-kkwbkig3-9a5131f514651ad406056abe74c531f0{\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:5px;\n}\n.avia-section.av-kkwbkig3-9a5131f514651ad406056abe74c531f0 .av-section-color-overlay{\nopacity:0.8;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-kkwbkig3-9a5131f514651ad406056abe74c531f0 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-16  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-7098'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-9jg91c-b0c4438ea2cbc450d2a399531635fb40 sc-av_four_fifth av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9jg91c-b0c4438ea2cbc450d2a399531635fb40\">\n#top .flex_column_table.av-equal-height-column-flextable.av-9jg91c-b0c4438ea2cbc450d2a399531635fb40{\nmargin-top:5px;\nmargin-bottom:5px;\n}\n.flex_column.av-9jg91c-b0c4438ea2cbc450d2a399531635fb40{\nborder-width:2px;\nborder-style:solid;\nborder-radius:5px 5px 5px 5px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9jg91c-b0c4438ea2cbc450d2a399531635fb40 av_four_fifth  avia-builder-el-17  el_before_av_four_fifth  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><article  class='iconbox iconbox_left_content av-kkwbluq2-e0b670079d596edbd42eff0ffd1eb585 av-icon-style-no-border  avia-builder-el-18  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue81e' data-av_iconfont='entypo-fontello'><\/div><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Extension Module Essential Requirements \"><h3 class='iconbox_content_title '  itemprop=\"headline\" >Extension Module Essential Requirements <\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>The BAYOOSOFT Risk Manager uses the set of normative requirements according to MDR 2017\/745 in the extension module <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#essential-requirements-mdr-ivdr\">Essential Requirements<\/a>. This makes gelingt particularly easy:<\/p>\n<p>the classification of the medical device according to MDR classes<br \/>\nthe verification of compliance with essential requirements by means of an interactive list<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9jg91c-44e3b723f53380455c4cf5b57273461a\">\n.flex_column.av-9jg91c-44e3b723f53380455c4cf5b57273461a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9jg91c-44e3b723f53380455c4cf5b57273461a av_four_fifth  avia-builder-el-19  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kkwbmis7-7c476df31e34a76ca4b613868c7b4c98 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a<strong> validated classifier according to MDR 2017\/745<\/strong>, the BAYOOSOFT Risk Manager provides manufacturers with an initial indication of the classification of the medical device by means of a questionnaire. In addition, only a justification is required, taking into account the intended purpose and the associated risks.<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_6'  class='avia-section av-kkwbkig3-d93d9ff67625d31f5225ed78fe794e5b main_color avia-section-default avia-no-border-styling  avia-builder-el-21  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-7098'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9jg91c-44e3b723f53380455c4cf5b57273461a\">\n.flex_column.av-9jg91c-44e3b723f53380455c4cf5b57273461a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9jg91c-44e3b723f53380455c4cf5b57273461a av_four_fifth  avia-builder-el-22  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-2ehkt6-18f2a02341161ecb0d6f831e52d4480b\">\n#top .av-special-heading.av-2ehkt6-18f2a02341161ecb0d6f831e52d4480b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-2ehkt6-18f2a02341161ecb0d6f831e52d4480b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-2ehkt6-18f2a02341161ecb0d6f831e52d4480b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-2ehkt6-18f2a02341161ecb0d6f831e52d4480b av-special-heading-h2 blockquote modern-quote  avia-builder-el-23  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Save valuable working time and thus accelerate the approval 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-kkwbmis7-7c476df31e34a76ca4b613868c7b4c98 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a fully automated and intelligent software solution, the BAYOOSOFT Risk Manager offers precisely these advantages. While the technical documentation is analysed and checked for inconsistencies after the programme starts, a self-learning knowledge database is generated from all the documentation created to date and provides valuable implementation assistance.<\/p>\n<p>Users are guided through the process quickly and easily. The dashboards provide an overview of where one is in the process at any given moment &#8211; regardless of whether one is<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7cim32-95a407e05a49f60ca51d05b1df032024\">\n.av_font_icon.av-7cim32-95a407e05a49f60ca51d05b1df032024 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-7cim32-95a407e05a49f60ca51d05b1df032024 avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p>Requirements Management<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-587wwu-51818b798d7f9b7ab64115b5e7e45af7\">\n.av_font_icon.av-587wwu-51818b798d7f9b7ab64115b5e7e45af7 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-587wwu-51818b798d7f9b7ab64115b5e7e45af7 avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p>Risk Analysis<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4h1ov2-e13ee9788c34cc7272c19f388a1de3d8\">\n.av_font_icon.av-4h1ov2-e13ee9788c34cc7272c19f388a1de3d8 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-4h1ov2-e13ee9788c34cc7272c19f388a1de3d8 avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p>Usability Engineering<\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bw4ku-ceda70ea15b3a7498f1eaf0ba3f2a2d9\">\n.av_font_icon.av-2bw4ku-ceda70ea15b3a7498f1eaf0ba3f2a2d9 .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-2bw4ku-ceda70ea15b3a7498f1eaf0ba3f2a2d9 avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue832' data-av_iconfont='entypo-fontello' ><\/span><\/span>\n<p>Clinical Evaluation<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kkwbmis7-7c476df31e34a76ca4b613868c7b4c98 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Proof of conformity with the <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#machinerydirective\">Machinery Directive<\/a> and the standard for medical electrical equipment.<\/p>\n<p>Another advantage of the software solution: Based on pre-configured standard processes, the BAYOOSOFT Risk Manager is<strong> ready for immediate use<\/strong>. Extension modules also enable the standard-compliant creation of the usability engineering file according to IEC 62366, the conformity report according to ISO 60601-1 as well as the fulfilment of the essential requirements according to IVDR 2017\/746.<\/p>\n<\/div><\/section><br \/>\n<div  class='av_promobox av-ko17pz6s-7a3a4c824ad59a1c51c40f683ce62f4f avia-button-yes  avia-builder-el-30  el_after_av_textblock  avia-builder-el-last '><div class='avia-promocontent'><p>\nYou would like to test the BAYOOSOFT Risk Manager free of charge? Sign up for a 30-day TRIAL.<\/p>\n<\/div><div  class='avia-button-wrap av-ko17pz6s-583531babcce011d15fd59bc8f5e5c47-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now\/'  class='avia-button av-ko17pz6s-583531babcce011d15fd59bc8f5e5c47 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Test Now\"><span class='avia_iconbox_title' >Test Now<\/span><\/a><\/div><\/div><\/p><\/div>\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":344,"featured_media":7057,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-7098","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7098","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\/344"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=7098"}],"version-history":[{"count":6,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7098\/revisions"}],"predecessor-version":[{"id":8249,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7098\/revisions\/8249"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/7057"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=7098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/categories?post=7098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/tags?post=7098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}