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IEC 62304
IEC 62304 software lifecycle evidence guide
Software lifecycle evidence should connect software requirements, architecture, implementation, verification, validation context, release, maintenance, and change control.
Core evidence to prepare
- Software safety classification rationale.
- Software requirements and architecture.
- Implementation and unit/integration verification evidence.
- SOUP and third-party component rationale.
- Maintenance and change-control evidence.
Why this matters
Reviewers and partners need evidence that is complete, traceable, and consistent across documents, not isolated claims.
How VigilySys helps
VigilySys helps connect this evidence into a controlled workspace where gaps, owners, and readiness status are visible.
Primary sources to review
Common questions
Is this checklist regulatory advice?
No. It is an educational readiness aid. Device-specific decisions require qualified professional review.
Can this be used before a demo?
Yes. It can help teams identify which evidence domains need deeper review before a device-context demo.
request a demo to turn this topic into a practical evidence-gap view for your device context.