Stage 07 of 12
Design verification
Demonstrate that design outputs meet approved design inputs.
Entry criteria
- Verification units and design baseline are controlled
- Requirements have approved acceptance criteria
- Protocols, methods, and equipment are ready
Required activities
- Execute bench, software, safety, EMC, and environmental testing
- Record deviations and investigate failures
- Maintain requirements-to-evidence traceability
- Repeat affected testing after controlled changes
Expected deliverables
- Approved verification protocols and reports
- Requirements traceability matrix
- Laboratory reports and certificates
- Failure investigations and dispositions
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Ambiguous acceptance criteria
- Testing nonrepresentative units
- Design changes invalidating completed evidence
Exit criteria
- All requirements have passing evidence or approved disposition
- Residual risks remain acceptable
- The validated production-equivalent configuration is defined
Suggested next actions
- Finalize validation protocols
- Confirm representative users and use environments
- Close verification-dependent regulatory sections
Find your next move
Build confidence in design verification.
Map your current evidence and gaps to the capabilities needed for this stage.