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SaMD readiness
SaMD evidence readiness checklist
SaMD teams can reduce late-stage surprises by checking evidence completeness before formal regulatory or partner review.
Core evidence to prepare
- Intended use and clinical context.
- Software lifecycle and requirements.
- Risk management and usability engineering.
- Cybersecurity, privacy, and data flows.
- Verification, validation, and submission readiness.
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.