The safety classes
The safety classes: A/B/C by harm severity, segregation strategy, and the FDA documentation distinction.
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IEC 62304 Software Lifecycle2026 Field Guide
The safety classes, the lifecycle, and the Edition 2 horizon — with the software discipline you need.
- Classes
- A/B/C
- 2026 draft
- Edition 2
- Rule
- SOUP
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The lifecycle
The lifecycle: planning to maintenance, the SOUP rule, and the SBOM expectation.
The Edition 2 horizon
The Edition 2 horizon: AI lifecycle, all-health-software scope, and the two-level simplification.
Sources & scope
- insoftex.com, Medical Device Software Development in 2026.
- github.com (pulseengine/rivet), Domain schema packages: IEC 62304.
- ailoitte.com, IEC 62304 Software Safety Classes A, B, C Explained.
- bermondseyelectronics.com, IEC 62304 Explained for Medical Device Software Teams.
This guide is market-access intelligence, not regulatory, engineering, or legal advice. Standards, editions, and regulatory expectations change — professional review is required before business use.
Market Access Strategy Session
Software on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your software route — classification, lifecycle planning, and Edition 2 readiness.
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