IEC 62304 Edition 2: What’s Changing, What’s Not, and How to Prepare 

IEC 62304, the international standard governing medical device software lifecycle processes, is undergoing its first major revision in nearly 20 years. While the upcoming second edition aims to clarify requirements and better reflect modern software practices, it also intentionally preserves the stability manufacturers rely on for compliance.  

This live webinar, co-presented with Medical Device HQ, provides a clear, practical view into the direction of IEC 62304 Edition 2, directly from someone involved in drafting the standard.  

In this session, Christian Kaestner, member of IEC TC 62 / SC 62A and contributor to IEC 62304 Edition 2, joins Tom Rish,  Head of GTM Strategy at Jama Software to explain what is changing, what is deliberately not changing, and what these updates mean in practice for medical device and Software as a Medical Device (SaMD) manufacturers. 

Key Takeaways:  

• Understand why IEC 62304 is being revised and the core objectives of Edition 2  
• Learn how the IEC standardization process has shaped the scope and content of the revision  
• Discover what the draft edition says about key topics like SaMD and artificial intelligence (AI).  
• Hear why AI will not be a significant part of IEC 62304 — a deliberate design choice you need to understand.  
• Find out which proposed changes are most likely to affect your organization and get practical advice on how to prepare.  

Get a grounded, standards-focused perspective on IEC 62304 Edition 2 and what it means for your software lifecycle processes.