{"id":9943,"date":"2026-09-03T10:17:26","date_gmt":"2026-09-03T08:17:26","guid":{"rendered":"https:\/\/use-lab.com\/?p=9943"},"modified":"2026-09-03T10:19:52","modified_gmt":"2026-09-03T08:19:52","slug":"usability-engineering-for-ai-based-medical-devices","status":"publish","type":"post","link":"https:\/\/use-lab.com\/en\/usability-engineering-for-ai-based-medical-devices\/","title":{"rendered":"Usability Engineering for AI-Based Medical Devices"},"content":{"rendered":"<p><strong>25 Years of Use-Lab. The Next 25 Years Start Now.<\/strong><\/p>\n<p>As part of our anniversary year 2026, Use-Lab is focusing on the questions that will shape the future of user-centered product development. One of these topics is the growing role of Artificial Intelligence in medical technology.<\/p>\n<p>On <strong>September 17, 2026<\/strong>, our colleague Thore Reitz will speak at <strong>Treffpunkt Medizintechnik in Frankfurt<\/strong> on the topic: <strong>\u201cUsability Engineering for AI-Based Medical Devices \u2013 Between Standards, Risk, and Real-World Use\u201d<\/strong><\/p>\n<p>Usability Engineering has become an established part of developing safe medical devices through regulatory frameworks such as MDR and IEC 62366-1 and is closely linked to risk management according to ISO 14971 as well as design processes. However, the introduction of AI- and ML-based systems creates new challenges that push established methods to their limits.<br \/>\nCurrent guidance documents, including the DKE position paper, the MDCG documents AIB 2025-1 \/ MDCG 2025-6, and FDA guidances, provide initial direction, but only partially address real-world use in clinical practice.<\/p>\n<p>The presentation will review the current state of the field, discuss key challenges from the users\u2019 perspective, and present practical approaches. Drawing on Use-Lab projects, particularly the INTERREG project DAME, it will demonstrate how Usability Engineering can evolve in the context of AI-based systems to improve safety, comprehensibility, and user acceptance.<\/p>\n<p><strong>Further information and registration:<\/strong> <a href=\"https:\/\/www.treffpunkt-medizintechnik.de\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.treffpunkt-medizintechnik.de\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>25 Years of Use-Lab. The Next 25 Years Start Now. As part of our anniversary year 2026, Use-Lab is focusing on the questions that will shape the future of user-centered product development. One of these topics is the growing role of Artificial Intelligence in medical technology. On September 17, 2026, our colleague Thore Reitz will [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[],"class_list":["post-9943","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/posts\/9943","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/comments?post=9943"}],"version-history":[{"count":1,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/posts\/9943\/revisions"}],"predecessor-version":[{"id":9944,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/posts\/9943\/revisions\/9944"}],"wp:attachment":[{"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/media?parent=9943"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/categories?post=9943"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/use-lab.com\/en\/wp-json\/wp\/v2\/tags?post=9943"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}