Objectives:
The purpose of Phase 4 - Design Verification & Validation is to verify that the product design meets the product specification and to validate that it meets the end-user’s intended use. Typically the design verification will include engineering testing of functional prototypes in a lab setting, and the design validation will include simulated use or clinical testing to confirm that user requirements are met.
Activities:
-
Build design verification units
-
Conduct design verification testing:
-
Reliability
-
Biocompatibility
-
Accelerated aging
-
Sterilization
-
Performance
-
Packaging evaluation
-
-
Build design validation units
-
Conduct design validation testing
-
Update Risk Management Plan
-
Prepare and submit regulatory submissions
-
Phase Review
Deliverables:
-
Design verification and validation protocol(s)
-
Design verification and validation units
-
Design verification and validation test reports
-
Shelf-life expiration dating
-
Regulatory submissions and approvals
