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

2 November 2026 · 8 min read

IEC 62304 Edition 2: what the revision means for medical device firmware

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.

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