{"id":3106,"date":"2024-04-28T14:58:59","date_gmt":"2024-04-28T14:58:59","guid":{"rendered":"https:\/\/healthlab.nrw\/software-as-medical-device\/"},"modified":"2025-04-09T14:41:59","modified_gmt":"2025-04-09T14:41:59","slug":"software-as-medical-device","status":"publish","type":"page","link":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/","title":{"rendered":"Software as Medical Device"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; back_color=&#8221;color-428319&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;185530&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;mobile-full&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-121267&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;141725&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column_text text_color=&#8221;color-173812&#8243; uncode_shortcode_id=&#8221;174821&#8243; text_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;kruimelpad&#8221;]<a href=\"https:\/\/healthlab.nrw\/en\/academy\/companies\/\">back to the course overview<\/a>[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;133797&#8243;]<\/p>\n<h2>Software as Medical Device<\/h2>\n<p><strong>Overview &amp; Roadmap for CE Certification<\/strong><\/p>\n<p>For digital health start-ups, the CE marking process is in many cases a major challenge. The MDR regulation imposes strict requirements for placing medical devices on the market and monitoring them. This course provides a low-threshold, practical overview of the CE certification process to help you bring your software to the market as a medical device as quickly and safely as possible.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image media=&#8221;2646&#8243; media_width_use_pixel=&#8221;yes&#8221; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;950204&#8243; media_width_pixel=&#8221;500&#8243; el_class=&#8221;full-english&#8221;][\/vc_column_inner][\/vc_row_inner][vc_raw_html]PGgzIGNsYXNzPSJpbmxpbmUtaDMiPkNvdXJzZSBDb250ZW50PC9oMz48c3BhbiBjbGFzcz0ia3Vyc21vZHVsZSI+MTAgQ291cnNlIE1vZHVsZXM8L3NwYW4+CjxwPlNlbGYtcGFjZWQgZGlnaXRhbCBtb2R1bGVzIHdpdGggYSBmaW5hbCBRJmFtcDtBIHNlc3Npb24gbGVkIGJ5IGluZHVzdHJ5IGV4cGVydHMuIDwvcD4=[\/vc_raw_html][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;115281&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs01&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;234956&#8243;]<strong>CE Certification Roadmap:<\/strong><br \/>Overview of relevant standards, laws, and regulations to guide you through the legally compliant CE marking process within the EU.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;612150&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs02&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;748652&#8243;]<strong>Intended Use &amp; Risk Classification<\/strong><br \/>When is software considered a medical device? Focus on Rule 11 of the MDR and MDCG 2019-11.  <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;129606&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs03&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;553208&#8243;]<strong>General Safety and Performance Requirements<br \/><\/strong>In-depth look at Annex I of the MDR and key requirements for product safety and efficacy.  <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;757952&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs04&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;172366&#8243;]<strong>Quality Management According to ISO 13485<br \/><\/strong>Standards for managing quality processes in medical device manufacturing.   <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;127274&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs05&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;193638&#8243;]<strong>Risk Management According to ISO 14971<br \/><\/strong>Structured approach to identifying, assessing, and controlling product risks.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;204213&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs06&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;544589&#8243;]<strong>Clinical Evaluation<br \/><\/strong>Systematic analysis of clinical data to confirm product safety and performance.  <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;101070&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs07&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;117286&#8243;]<strong>Technical Documentation<br \/><\/strong>Comprehensive documentation of design, function, and regulatory compliance, especially for digital products.  <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;187663&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs08&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;161085&#8243;]<strong>Conformity Assessment &amp; Market Launch<br \/><\/strong>Covers instructions for use, PRRC, UDI, databases like EUDAMED, and CE marking.   <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;638789&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs09&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;111166&#8243;]<strong>Post-Market Surveillance (PMS)<br \/><\/strong>Ongoing monitoring after market launch to ensure continued product safety.  <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; back_color=&#8221;color-396893&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;122856&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;border kurs-block kurs10&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;684667&#8243;][vc_column_text uncode_shortcode_id=&#8221;139115&#8243;]<strong>Special Requirements for Risk Class II and Above<br \/><\/strong>Includes audits, PMS reporting, safety update reports, cybersecurity, and more.   <br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;109788&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;170643&#8243;]<\/p>\n<h3 class=\"h4\">Q&amp;A Session<\/h3>\n<p>Interactive session with industry experts to discuss course topics and your questions.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;671637&#8243;]<\/p>\n<h3 class=\"h4\">Methods<\/h3>\n<ul class=\"plus-orange\">\n<li>Web lectures<\/li>\n<li>Practical tutorials<\/li>\n<li>Supporting literature and course script<\/li>\n<li>Real-life examples and templates<\/li>\n<li>Live Q&amp;A with industry experts<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;109788&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/1&#8243;][vc_column_text uncode_shortcode_id=&#8221;619309&#8243;]<\/p>\n<h3 class=\"h4\">Target Audience<\/h3>\n<p>This course is designed for everyone involved in the development and commercialization of digital health solutions, including:<\/p>\n<ul class=\"plus-orange\">\n<li>Founders<\/li>\n<li>Software developers and architects<\/li>\n<li>Project managers<\/li>\n<li>Regulatory affairs and quality management professionals<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;207849&#8243; el_class=&#8221;border-kurse&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;269530&#8243;]<\/p>\n<h3 class=\"h4\">Instructor<\/h3>\n<p>[\/vc_column_text][vc_column_text el_class=&#8221;extrainfo&#8221; uncode_shortcode_id=&#8221;193251&#8243;]<\/p>\n<div class=\"image-caption-container\"><img decoding=\"async\" src=\"https:\/\/healthlab.nrw\/wp-content\/uploads\/2024\/04\/angela-specht.png\"><span class=\"caption\"><strong>Angela Specht<\/strong><br \/>Regulatory Affairs Specialist, KREWI Medical Produkte GmbH<\/span><\/div>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_empty_space empty_h=&#8221;2&#8243; medium_visibility=&#8221;yes&#8221; mobile_visibility=&#8221;yes&#8221; el_class=&#8221;extra-top-padding&#8221;][vc_column_text uncode_shortcode_id=&#8221;195487&#8243;]<\/p>\n<div class=\"image-caption-container\"><img decoding=\"async\" src=\"https:\/\/healthlab.nrw\/wp-content\/uploads\/2024\/04\/ilja-michaelis.png\"><span class=\"caption\"><strong>Ilja Michaelis<\/strong><br \/>Gesch\u00e4ftsf\u00fchrer Routine Health GmbH<\/span><\/div>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;661073&#8243; el_class=&#8221;max-560&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text uncode_shortcode_id=&#8221;140306&#8243;]<\/p>\n<h3 class=\"h4\">Investment<\/h3>\n<p>\u20ac299 excl. VAT[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_button button_color=&#8221;color-173812&#8243; size=&#8221;btn-lg&#8221; hover_fx=&#8221;full-colored&#8221; border_width=&#8221;0&#8243; scale_mobile=&#8221;no&#8221; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;187007&#8243; link=&#8221;url:mailto%3Aacademy%40healthlab.nrw%3Fsubject%3DMeine%2520Anmeldung%2520zum%2520Onlinekurs%2520Software%2520als%2520Medizinprodukt%26amp%3Bbody%3DBitte%2520Namen%2C%2520Telefonnummer%2520und%2520Rechnungsadresse%2520angeben.%2520Die%2520Investition%2520pro%2520Person%2520ist%2520299%2520Euro.|&#8221;]Sign up now[\/vc_button][\/vc_column_inner][\/vc_row_inner][vc_column_text text_lead=&#8221;small&#8221; el_class=&#8221;buttoninfo&#8221; uncode_shortcode_id=&#8221;160209&#8243;]<\/p>\n<p style=\"text-align: center;\"><strong>Registration open at any time.<\/strong><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;2&#8243; back_color=&#8221;color-428319&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;185530&#8243; back_color_type=&#8221;uncode-palette&#8221; el_class=&#8221;mobile-full&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-121267&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1454,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3106","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Software as Medical Device<\/title>\n<meta name=\"description\" content=\"For digital health start-ups, the CE marking process is in many cases a major challenge.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Software as Medical Device\" \/>\n<meta property=\"og:description\" content=\"For digital health start-ups, the CE marking process is in many cases a major challenge.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"Healthlab NRW\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-09T14:41:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/healthlab.nrw\/wp-content\/uploads\/2020\/12\/andreas-rothgangel.png\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/\",\"url\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/\",\"name\":\"Software as Medical Device\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/healthlab.nrw\\\/wp-content\\\/uploads\\\/2020\\\/12\\\/andreas-rothgangel.png\",\"datePublished\":\"2024-04-28T14:58:59+00:00\",\"dateModified\":\"2025-04-09T14:41:59+00:00\",\"description\":\"For digital health start-ups, the CE marking process is in many cases a major challenge.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/#primaryimage\",\"url\":\"https:\\\/\\\/healthlab.nrw\\\/wp-content\\\/uploads\\\/2020\\\/12\\\/andreas-rothgangel.png\",\"contentUrl\":\"https:\\\/\\\/healthlab.nrw\\\/wp-content\\\/uploads\\\/2020\\\/12\\\/andreas-rothgangel.png\",\"width\":600,\"height\":600},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/software-as-medical-device\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/healthlab.nrw\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Software as Medical Device\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#website\",\"url\":\"https:\\\/\\\/healthlab.nrw\\\/\",\"name\":\"Healthlab NRW\",\"description\":\"En nog een WordPress site\",\"publisher\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/healthlab.nrw\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#organization\",\"name\":\"Healthcare Living Lab\",\"url\":\"https:\\\/\\\/healthlab.nrw\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Healthcare Living Lab\"},\"image\":{\"@id\":\"https:\\\/\\\/healthlab.nrw\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/nl.linkedin.com\\\/in\\\/andreas-rothgangel-b4a1816b\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Software as Medical Device","description":"For digital health start-ups, the CE marking process is in many cases a major challenge.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/","og_locale":"en_US","og_type":"article","og_title":"Software as Medical Device","og_description":"For digital health start-ups, the CE marking process is in many cases a major challenge.","og_url":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/","og_site_name":"Healthlab NRW","article_modified_time":"2025-04-09T14:41:59+00:00","og_image":[{"width":600,"height":600,"url":"https:\/\/healthlab.nrw\/wp-content\/uploads\/2020\/12\/andreas-rothgangel.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/","url":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/","name":"Software as Medical Device","isPartOf":{"@id":"https:\/\/healthlab.nrw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/#primaryimage"},"image":{"@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/#primaryimage"},"thumbnailUrl":"https:\/\/healthlab.nrw\/wp-content\/uploads\/2020\/12\/andreas-rothgangel.png","datePublished":"2024-04-28T14:58:59+00:00","dateModified":"2025-04-09T14:41:59+00:00","description":"For digital health start-ups, the CE marking process is in many cases a major challenge.","breadcrumb":{"@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/healthlab.nrw\/en\/software-as-medical-device\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/#primaryimage","url":"https:\/\/healthlab.nrw\/wp-content\/uploads\/2020\/12\/andreas-rothgangel.png","contentUrl":"https:\/\/healthlab.nrw\/wp-content\/uploads\/2020\/12\/andreas-rothgangel.png","width":600,"height":600},{"@type":"BreadcrumbList","@id":"https:\/\/healthlab.nrw\/en\/software-as-medical-device\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/healthlab.nrw\/en\/"},{"@type":"ListItem","position":2,"name":"Software as Medical Device"}]},{"@type":"WebSite","@id":"https:\/\/healthlab.nrw\/#website","url":"https:\/\/healthlab.nrw\/","name":"Healthlab NRW","description":"En nog een WordPress site","publisher":{"@id":"https:\/\/healthlab.nrw\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/healthlab.nrw\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/healthlab.nrw\/#organization","name":"Healthcare Living Lab","url":"https:\/\/healthlab.nrw\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/healthlab.nrw\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Healthcare Living Lab"},"image":{"@id":"https:\/\/healthlab.nrw\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/nl.linkedin.com\/in\/andreas-rothgangel-b4a1816b"]}]}},"_links":{"self":[{"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/pages\/3106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/comments?post=3106"}],"version-history":[{"count":0,"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/pages\/3106\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/media\/1454"}],"wp:attachment":[{"href":"https:\/\/healthlab.nrw\/en\/wp-json\/wp\/v2\/media?parent=3106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}