Webinars - How to Build AI-Enabled Medical Devices Under IEC 62304 Edition 2 - Ketryx Compliance Framework
How to Build AI-Enabled Medical Devices Under IEC 62304 Edition 2
September 9, 2026, 11:00 am EST • 60 mins
IEC 62304 Edition 2, targeted for publication in August 2026, brings the biggest structural change to medical device software development in nearly two decades. Three safety classes collapse into two rigor levels, AI and ML development gets its own defined lifecycle, and the standard's scope expands to cover all health software, not just regulated devices. This session draws on what we're hearing from enterprise medical device companies as they plan their implementation.
What you'll learn
- An overview of Edition 2 and the key changes from Edition 1
- Where enterprise teams are finding gaps in their current processes and open questions as they plan for the new standard
- How risk management practices need to evolve for AI-enabled devices, including new expectations for AI/ML risk controls and monitoring
- How to build a 62304 Edition 2 compliant AI-enabled medical device with an AI-native approach
Who should attend
Speakers
Eric Henry
Senior Advisor, Head of Quality Compliance
Formerly
Tim Brodeur
VP, Success & Delivery
Formerly
VP, Customer Success, Causaly; Global Head of GxP, Benchling; Director, R&D Customer Success, Veeva