In this webinar, 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.
