FREE ON DEMAND WEBINAR

Navigating AI in medical devices & healthcare – from hype to harmonization!

This webinar offers a focused deep dive into the Medical Device Regulation (MDR) and the new EU Artificial Intelligence Act, shedding light on their overlaps, critical gaps, and upcoming obligations. Gain direct insights from industry experts, including Notified Body representatives, as we explore how AI impacts not only product design but also key supporting processes such as QMS, risk management, cybersecurity, and usability.

What to expect:

• Key trends and an overview of certified AI-enabled medical devices
• The evolving role of AI beyond the product, its impact on QMS, risk management, usability, cybersecurity, and more
• Structured guidance for navigating regulatory uncertainty
• Achievements in harmonization: standards, guidelines, and best practices
• Conformity assessment and certification requirements under MDR and the AI Act