Bureau Veritas at the TS Quality & Engineering Webinar • Medical Device with Artificial Intelligence

The rapid integration of artificial intelligence into medical devices is reshaping regulatory expectations across the European landscape. This webinar provides essential guidance from a Notified Body perspective (NB 1370), focusing on the intersection between AI technologies and medical device regulation.

Participants will gain a clear understanding of the relationship between the EU Medical Device Regulation (MDR) and the EU Artificial Intelligence Act (AIA), including their combined impact on market access and compliance strategies. 

The session will explore the additional regulatory requirements applicable to AI-enabled medical devices. In addition, the webinar will address practical considerations for manufacturers, with a focus on change management approaches when integrating AI into regulated product lifecycles.

Attendees will leave with actionable insights to support compliant development, maintenance, and evolution of AI-driven medical devices within the EU regulatory framework.