{"id":5914,"date":"2024-09-24T14:03:41","date_gmt":"2024-09-24T12:03:41","guid":{"rendered":"http:\/\/dev.ornet-service.com\/?page_id=5914"},"modified":"2024-09-25T10:51:10","modified_gmt":"2024-09-25T08:51:10","slug":"konformitaetsbewertung-und-regulatorische-anforderungen","status":"publish","type":"page","link":"https:\/\/ornet.org\/?page_id=5914","title":{"rendered":"Konformit\u00e4tsbewertung und regulatorische Anforderungen"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-6lu5l6-09f9a0851f721bdfd5088f23dc430b8e main_color avia-section-default avia-no-border-styling  avia-builder-el-0  avia-builder-el-no-sibling  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-5914'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m1hljvyr-baef70fe8bdb7235e5918e9ccebd5826\">\n.av_font_icon.av-m1hljvyr-baef70fe8bdb7235e5918e9ccebd5826 .av-icon-char{\nfont-size:40px;\nline-height:40px;\nwidth:40px;\n}\n<\/style>\n<span  class='av_font_icon av-m1hljvyr-baef70fe8bdb7235e5918e9ccebd5826 avia_animate_when_visible av-icon-style-border avia-icon-pos-center avia-iconfont avia-font-entypo-fontello av-no-color avia-icon-animate'><span class='av-icon-char' data-av_icon='\ue84e' data-av_iconfont='entypo-fontello' aria-hidden=\"true\" ><\/span><\/span>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3q1fze-6c242faeaba173425c6ef57bb3946344\">\n#top .hr.hr-invisible.av-3q1fze-6c242faeaba173425c6ef57bb3946344{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-3q1fze-6c242faeaba173425c6ef57bb3946344 hr-invisible  avia-builder-el-2  el_after_av_font_icon  el_before_av_textblock '><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-m1hllwmq-633d8fb2573aaf1b179f29ceab69584d\">\n#top .av_textblock_section.av-m1hllwmq-633d8fb2573aaf1b179f29ceab69584d .avia_textblock{\ncolor:#104370;\n}\n<\/style>\n<section  class='av_textblock_section av-m1hllwmq-633d8fb2573aaf1b179f29ceab69584d '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><div class=\"vc_row wpb_row vc_row-fluid vc_row-stretch\" data-vc-full-width=\"true\" data-vc-full-width-init=\"true\">\n<div class=\"wpb_column vc_column_container vc_col-sm-12\">\n<div class=\"vc_column-inner \">\n<div class=\"wpb_wrapper\">\n<div class=\"vntd-icon-box vntd-content-element box-centered-circle icon-size-medium box-centered\">\n<div class=\"icon-box-content\">\n<div class=\"vc_row wpb_row vc_row-fluid vc_row-stretch\" data-vc-full-width=\"true\" data-vc-full-width-init=\"true\">\n<div class=\"wpb_column vc_column_container vc_col-sm-12\">\n<div class=\"vc_column-inner \">\n<div class=\"wpb_wrapper\">\n<div class=\"vntd-icon-box vntd-content-element box-centered-circle icon-size-medium box-centered\">\n<div class=\"icon-box-content\">\n<h3 class=\"icon-box-title\" style=\"text-align: center;\"><strong>Konformit\u00e4tsbewertung und regulatorische Anforderungen<\/strong><\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2xhht6-7eb2ab8251821ad67ac120c128d2bb51\">\n#top .hr.hr-invisible.av-2xhht6-7eb2ab8251821ad67ac120c128d2bb51{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-2xhht6-7eb2ab8251821ad67ac120c128d2bb51 hr-invisible  avia-builder-el-4  el_after_av_textblock  el_before_av_toggle_container '><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-m1hlml6z-d0d115325279de81fbd5b88bf8ee973c\">\n#top .togglecontainer.av-m1hlml6z-d0d115325279de81fbd5b88bf8ee973c p.toggler.activeTitle{\ncolor:#104370;\nborder-color:#104370;\n}\n<\/style>\n<div  class='togglecontainer av-m1hlml6z-d0d115325279de81fbd5b88bf8ee973c av-elegant-toggle  avia-builder-el-5  el_after_av_hr  avia-builder-el-last  hasCurrentStyle' >\n<section class='av_toggle_section av-m1hlm7ym-66265afbd71cc20d86425f6f71f12518'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Alle} \"  ><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=\"Aufgaben der Arbeitsgruppe\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Aufgaben der Arbeitsgruppe\" data-aria_expanded=\"Click to collapse: Aufgaben der Arbeitsgruppe\">Aufgaben der Arbeitsgruppe<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\" ><ul>\n<li>Strategieentwicklung der Rolle des OR.NET e.V. bei der Konformit\u00e4tsbewertung und -erkl\u00e4rung von SDC f\u00e4higen Systemen. Einschlie\u00dflich der Rolle von Testh\u00e4usern (OR.NET als Betreiber oder Zertifizierer)<\/li>\n<li>Konzeptentwicklung zur Konformit\u00e4tsbewerbung (SDC ready, SDC, SDC v2, \u2026) und Markenvergabe<\/li>\n<li>Kommunikation und Abstimmung mit Benannten Stellen (z.B. \u00fcber IG-NB) zur Etablierung der OR.NET-Strategie zur Zulassung von offen vernetzen Medizinprodukten<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-m1hlmk1i-ba8dd2308a981b8bafbb70279858aba9'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Alle} \"  ><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=\"Ansprechperson\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Ansprechperson\" data-aria_expanded=\"Click to collapse: Ansprechperson\">Ansprechperson<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>Bitte richten Sie Fragen zu Themen dieser Arbeitsgruppe oder Anfragen zur Mitarbeit direkt an die entsprechenden Ansprechpersonen.<br \/>\n<br class=\"avia-permanent-lb\" \/>Armin Jan\u00df: janss@hia.rwth-aachen.de<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-5914'><div class='entry-content-wrapper clearfix'>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":5906,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5914","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/pages\/5914","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ornet.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5914"}],"version-history":[{"count":4,"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/pages\/5914\/revisions"}],"predecessor-version":[{"id":6094,"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/pages\/5914\/revisions\/6094"}],"up":[{"embeddable":true,"href":"https:\/\/ornet.org\/index.php?rest_route=\/wp\/v2\/pages\/5906"}],"wp:attachment":[{"href":"https:\/\/ornet.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5914"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}