AI in Medical Devices: Understanding the Review Process and Common Gaps

Free webinar with BSI and GBA Key2Compliance

As artificial intelligence becomes increasingly integrated into medical devices, manufacturers face new challenges in demonstrating regulatory compliance. Understanding how AI is assessed, what notified bodies look for, and where common gaps arise is important when preparing for regulatory assessment.

Join GBA Key2Compliance and BSI for a free webinar where Thomas Doerge from BSI will share insights into the review process for AI-enabled medical devices, its interaction with conformity assessments under the EU Medical Device Regulation (MDR), and important considerations for manufacturers.

The session will be moderated by Oscar He Lindholm from GBA Key2Compliance.

What you will learn

• The review process: Key aspects of the review process for AI-enabled medical devices.
• Interaction with MDR: How AI-related considerations interact with the MDR conformity assessment process.
• Common gaps: Typical gaps and challenges manufacturers should be aware of.
• Important considerations: Key points to keep in mind when preparing for regulatory assessment.

The webinar offers an opportunity to gain insights from a notified body’s perspective and better understand the challenges manufacturers may encounter during the regulatory review process.

Who should attend?
This webinar is particularly relevant for medical device manufacturers, software developers, and professionals working with Regulatory Affairs, Quality Assurance, and the development of AI-enabled medical devices.

Webinar details
Date: 19 November 2026
Time: 13:00–14:00 CET
Location: Online
Cost: Free of charge

Speaker: Thomas Doerge, Global Head Active Implantable Medical Devices and SaMD, BSI
Moderator: Oscar He Lindholm, Client & Business Development Partner, GBA Key2Compliance

Register now to gain valuable insights into the regulatory review process for AI-enabled medical devices.