---
title: "Articles on Medical Device Firmware and IEC 62304 | Compen Embedded"
description: "Practical insights on medical device firmware, IEC 62304 and the regulations around it, from the engineers at Compen Embedded."
image: "https://compen.net/og-image.jpg"
---

# Articles

Practical insights on medical device firmware, IEC 62304 and the regulations around it, from the engineers at Compen Embedded.

## [IEC 62304 Edition 2: what the revision means for medical device firmware](https://compen.net/articles/iec-62304-edition-2)

2 November 2026 · 8 min read

The second edition of IEC 62304 replaces software safety classes A, B and C with two process rigour levels and widens the scope to all health software. Where the revision stands, what changes, and what to do now.