Starting in August 2026, the high-risk requirements set forth in Articles 9 through 17 of the EU AI Act will apply in addition to the Medical Device Regulation (MDR). Nearly all AI-based “Software as a Medical Device” (SaMD) in Classes IIa through III will automatically fall under these requirements. If your Quality Management System (QMS) reliably complies with the MDR today, the key question is not whether the AI Act affects you, but how well your QMS is already prepared for it.
In this concise webinar, Torsten Herbert from sepp.med will show you the 5 gaps where MedTech companies most frequently fall short during audits. In 20 minutes, you’ll receive an honest assessment of your current status and specific audit questions that you can apply directly to your own organization. Afterward, we’ll answer your questions in a moderated Q&A session.
IT managers and CTOs at medtech companies with AI-based Software as a Medical Device, as well as Regulatory Affairs Managers who coordinate audit preparation
Torsten Herbert, Quality Engineer and Team Leader at sepp.med
Termin: July 7 2026, 11:00 a.m.Duration: 20 minutes + Q&A
Secure your free spot now and gain clarity on your AI Act readiness before the August 2026 deadline limits your options. Participation is free of charge; you will receive a recording and the presentation via email after the webinar. Register now!
Torsten Herbert studied physics at the Justus Liebig University in Giessen, specializing in applied physics - sensor technology.
After gaining more than eleven years of practical experience as a software developer in various industries, he joined sepp.med in 2006 in the field of software quality assurance and is now team leader.
He has multiple certifications, including CTFL, CTFL-AuT and CTAL TM, and has extensive experience as an IT consultant, project manager and test manager.
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