Regulated release-readiness assessment protocol
A regulated release-readiness assessment is a scored protocol run before every release, and its go/no-go threshold is explicit: 100% of ISO 14971 risk controls verified, 100% of planned verification executed, and 0 requirements with a gap in the requirements traceability matrix.
"All tests pass" is not a release decision, and a release-readiness threshold is not a subjective sign-off.
Why "tests are green" isn't a release decision
A release-readiness assessment exists because verification and validation are each necessary but neither is sufficient alone — see Verification vs. Validation. A regulated release gate checks both, plus two things a test suite never proves on its own: that 100% of ISO 14971 risk controls are verified, and that the requirements traceability matrix is actually closed, not just mostly closed.
Go/no-go scoring rubric
| Gate | Pass condition | Weight |
|---|---|---|
| Verification complete | 100% of planned unit/integration/system verification executed and passed, or deviations formally dispositioned | Blocking |
| Validation complete | Validation activities against user needs/intended use are complete and documented | Blocking |
| Risk controls verified | 100% of ISO 14971 risk controls have a linked verification record | Blocking |
| Traceability closed | 0 requirements with an unresolved traceability gap (see the traceability matrix) | Blocking |
| Open problem reports | 0 open reports classified as safety-relevant; non-safety reports dispositioned | Blocking |
Every gate above is blocking in a regulated release — there is no weighted-average "mostly ready" score. One unresolved blocking gate means the release does not go.
Printable release-readiness checklist
[ ] Verification: 100% planned activities executed; deviations dispositioned
[ ] Validation: activities complete against documented user needs
[ ] Risk controls: 100% have a linked, passed verification record
[ ] Traceability: 0 unresolved requirement -> test -> risk-control gaps
[ ] Problem reports: 0 open safety-relevant reports
[ ] Release record: references all of the above by ID, signed by quality
approvalEngineering reference protocol only. Not formal regulatory counsel, not a substitute for your own quality system's release-approval process.
Useful next step
Provenance & review state
- Last reviewed
- Sources
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- IEC 62304:2006+AMD1:2015 — International Electrotechnical Commission
- ISO 14971:2019 — International Organization for Standardization
- Ingested from
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