{"id":3423,"date":"2026-02-24T11:09:34","date_gmt":"2026-02-24T09:09:34","guid":{"rendered":"https:\/\/biophot.lv\/?p=3423"},"modified":"2026-02-24T11:13:03","modified_gmt":"2026-02-24T09:13:03","slug":"eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices","status":"publish","type":"post","link":"https:\/\/biophot.lv\/en\/aicinam-uz-vebinaru-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/","title":{"rendered":"Welcome to the webinar \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d"},"content":{"rendered":"<p><strong>Join us for a webinar on the regulation of software and artificial intelligence in medical technology. MDR, IVDR and the EU Artificial Intelligence Act are placing increasingly detailed requirements on developers of digital health solutions, so a clear understanding of qualifications, classification and compliance is essential early in development.<\/strong><\/p>\n\n\n\n<p><strong>The webinar will take place on 17 March at 10.00.<\/strong><\/p>\n\n\n\n<p>The webinar will be moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Affairs Advisor, specialising in early-stage innovation project support and CE marking strategy.<\/p>\n\n\n\n<p>\u200b<strong>Topics covered in the webinar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>How to determine whether software qualifies as a medical device or in vitro diagnostic under the MDR\/IVDR<\/li>\n\n\n\n<li>Classification of software and in vitro diagnostic software and its impact on regulatory requirements<\/li>\n\n\n\n<li>Conformity assessment requirements, including technical documentation, cybersecurity and clinical or performance evidence<\/li>\n\n\n\n<li>Standards applicable to software and AI, including IEC 62304, ISO 14971 and IEC 82304-1<\/li>\n\n\n\n<li>Requirements for artificial intelligence and machine learning systems, including data management, transparency and validation<\/li>\n\n\n\n<li>The interplay between the EU AI Act and MDR\/IVDR and the role of double compliance in practice<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p>Norise: Zoom platform<\/p>\n\n\n\n<p>Working language: english<\/p>\n\n\n\n<p><strong>Registration:<\/strong>&nbsp;<a href=\"https:\/\/luma.com\/dki2q09z\">https:\/\/luma.com\/dki2q09z<\/a><\/p>\n\n\n\n<p>Participants are invited to send their questions by 13 March by e-mail:&nbsp;<a>inovacija@rsu.lv<\/a><\/p>\n\n\n\n<p>Please note that the webinar will be recorded.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Aicin\u0101m pievienoties vebin\u0101ram par programmat\u016bras un m\u0101ksl\u012bg\u0101 intelekta regul\u0113jumu medic\u012bnas tehnolo\u0123ij\u0101s. MDR, IVDR un ES M\u0101ksl\u012bg\u0101 intelekta akts izvirza arvien detaliz\u0113t\u0101kas pras\u012bbas digit\u0101l\u0101s vesel\u012bbas risin\u0101jumu izstr\u0101d\u0101t\u0101jiem, t\u0101p\u0113c skaidra izpratne par kvalifik\u0101ciju, klasifik\u0101ciju un atbilst\u012bbu ir b\u016btiska jau agr\u012bn\u0101 att\u012bst\u012bbas posm\u0101. Vebin\u0101rs norisin\u0101sies 17. mart\u0101, plkst. 10.00. Vebin\u0101ru vad\u012bs Stefans Boleiningers (Stefan Bolleininger), Consultys Medical vad\u012bt\u0101js [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3419,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[8,5],"tags":[],"class_list":["post-3423","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pasakums","category-pazinojums"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aicin\u0101m uz vebin\u0101ru \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d - BioPhoT<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biophot.lv\/en\/eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aicin\u0101m uz vebin\u0101ru \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d - BioPhoT\" \/>\n<meta property=\"og:description\" content=\"Aicin\u0101m pievienoties vebin\u0101ram par programmat\u016bras un m\u0101ksl\u012bg\u0101 intelekta regul\u0113jumu medic\u012bnas tehnolo\u0123ij\u0101s. MDR, IVDR un ES M\u0101ksl\u012bg\u0101 intelekta akts izvirza arvien detaliz\u0113t\u0101kas pras\u012bbas digit\u0101l\u0101s vesel\u012bbas risin\u0101jumu izstr\u0101d\u0101t\u0101jiem, t\u0101p\u0113c skaidra izpratne par kvalifik\u0101ciju, klasifik\u0101ciju un atbilst\u012bbu ir b\u016btiska jau agr\u012bn\u0101 att\u012bst\u012bbas posm\u0101. Vebin\u0101rs norisin\u0101sies 17. mart\u0101, plkst. 10.00. 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