{"id":3864,"date":"2026-04-09T16:06:27","date_gmt":"2026-04-09T13:06:27","guid":{"rendered":"https:\/\/biophot.lv\/?p=3864"},"modified":"2026-04-09T16:06:51","modified_gmt":"2026-04-09T13:06:51","slug":"video-webinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices","status":"publish","type":"post","link":"https:\/\/biophot.lv\/en\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/","title":{"rendered":"VIDEO: Webinar \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d"},"content":{"rendered":"<p>In a webinar on software and artificial intelligence (AI\/ML) regulation in medical technologies, participants were introduced to the requirements of the MDR, IVDR, and the EU AI Act, which are becoming increasingly detailed for developers of digital health solutions. Special attention was given to the early understanding of qualification, classification, and compliance in preparation for CE marking.<\/p>\n\n\n\n<p>The webinar was led by Stefan Bolleininger, Head of Consultys Medical and Senior Regulatory Affairs Consultant, who specializes in supporting early-stage innovation projects.<\/p>\n\n\n\n<p>The webinar covered the following topics:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Software Qualification as a Medical Device or IVD under MDR\/IVDR<\/li>\n\n\n\n<li>Classification of Software and IVD Software and its Impact on Regulatory Requirements<\/li>\n\n\n\n<li>Conformity assessment, including technical documentation, cybersecurity, and clinical\/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>Artificial Intelligence and Machine Learning Systems Requirements: Data Management, Transparency, and Validation<\/li>\n\n\n\n<li>Interaction between the AI Act and MDR\/IVDR and the importance of dual compliance in practice<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Webinar \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/kM44_cuna4Q?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe>\n<\/div><\/figure>","protected":false},"excerpt":{"rendered":"<p>Vebin\u0101r\u0101 par programmat\u016bras un m\u0101ksl\u012bg\u0101 intelekta (AI\/ML) regul\u0113jumu medic\u012bnas tehnolo\u0123ij\u0101s dal\u012bbnieki tika iepazin\u0101ti ar MDR, IVDR un ES M\u0101ksl\u012bg\u0101 intelekta akta pras\u012bb\u0101m, kas digit\u0101l\u0101s vesel\u012bbas risin\u0101jumu izstr\u0101d\u0101t\u0101jiem k\u013c\u016bst arvien detaliz\u0113t\u0101kas. \u012apa\u0161a uzman\u012bba tika piev\u0113rsta agr\u012bnai izpratnei par kvalifik\u0101ciju, klasifik\u0101ciju un atbilst\u012bbu CE mar\u0137\u0113juma sagatavo\u0161an\u0101. Vebin\u0101ru vad\u012bja Stefans Boleiningers (Stefan Bolleininger), Consultys Medical vad\u012bt\u0101js un vec\u0101kais [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3865,"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-3864","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>VIDEO: Vebin\u0101rs \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\/video-webinars-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=\"VIDEO: Vebin\u0101rs \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d - BioPhoT\" \/>\n<meta property=\"og:description\" content=\"Vebin\u0101r\u0101 par programmat\u016bras un m\u0101ksl\u012bg\u0101 intelekta (AI\/ML) regul\u0113jumu medic\u012bnas tehnolo\u0123ij\u0101s dal\u012bbnieki tika iepazin\u0101ti ar MDR, IVDR un ES M\u0101ksl\u012bg\u0101 intelekta akta pras\u012bb\u0101m, kas digit\u0101l\u0101s vesel\u012bbas risin\u0101jumu izstr\u0101d\u0101t\u0101jiem k\u013c\u016bst arvien detaliz\u0113t\u0101kas. \u012apa\u0161a uzman\u012bba tika piev\u0113rsta agr\u012bnai izpratnei par kvalifik\u0101ciju, klasifik\u0101ciju un atbilst\u012bbu CE mar\u0137\u0113juma sagatavo\u0161an\u0101. Vebin\u0101ru vad\u012bja Stefans Boleiningers (Stefan Bolleininger), Consultys Medical vad\u012bt\u0101js un vec\u0101kais [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biophot.lv\/en\/video-webinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"BioPhoT\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-09T13:06:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-09T13:06:51+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biophot.lv\/wp-content\/uploads\/2026\/04\/Copy-of-1080-x-1080px-2-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ilze\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ilze\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\"},\"author\":{\"name\":\"Ilze\",\"@id\":\"https:\/\/biophot.lv\/#\/schema\/person\/b6835496fc3e60bba9412a8a135755f1\"},\"headline\":\"VIDEO: Vebin\u0101rs \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d\",\"datePublished\":\"2026-04-09T13:06:27+00:00\",\"dateModified\":\"2026-04-09T13:06:51+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\"},\"wordCount\":248,\"publisher\":{\"@id\":\"https:\/\/biophot.lv\/#organization\"},\"image\":{\"@id\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/biophot.lv\/wp-content\/uploads\/2026\/04\/Copy-of-1080-x-1080px-2-1.jpg\",\"articleSection\":[\"Pas\u0101kums\",\"Pazi\u0146ojums\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\",\"url\":\"https:\/\/biophot.lv\/video-vebinars-eu-regulations-for-software-and-artificial-intelligence-ai-ml-based-medical-devices\/\",\"name\":\"VIDEO: Vebin\u0101rs \u201cEU Regulations for Software and Artificial Intelligence (AI\/ML) Based Medical Devices\u201d - 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