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ISO 14971
ISO 14971 risk traceability guide
Risk management becomes submission evidence when hazards, harms, hazardous situations, controls, verification, and residual risk decisions remain traceable.
Core evidence to prepare
- Hazard and hazardous situation identification.
- Harm and severity rationale.
- Risk control option analysis.
- Risk control verification evidence.
- Residual risk and benefit-risk rationale.
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.