Medical Device Software Versioning

Medical Device made Easy Podcast · Aug 21, 2025

Managing Software Updates in Medical Devices: Best Practices & Pitfalls

In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304.

In this episode of our podcast, we dive into the critical aspects of software update management for medical devices:

Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of…