Stage 08 of 12
Validation
Confirm the product meets user needs in its intended use environment.
Entry criteria
- Verification is substantially complete
- Production-equivalent units are available
- Representative users and environments are defined
Required activities
- Conduct summative usability validation
- Execute clinical or performance validation where required
- Validate labeling, training, and workflow integration
- Assess validation findings against benefit-risk conclusions
Expected deliverables
- Usability validation report
- Clinical or performance evidence
- Validated labeling and training
- Updated benefit-risk assessment
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Nonrepresentative participants or environments
- Training that masks product usability problems
- Validation changes creating new verification needs
Exit criteria
- User needs and intended uses have objective validation evidence
- Critical use-related risks are controlled
- Validation evidence supports the submission strategy
Suggested next actions
- Assemble the submission package
- Complete final labeling review
- Prepare for authority questions
Find your next move
Build confidence in validation.
Map your current evidence and gaps to the capabilities needed for this stage.