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.


  • 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


  • 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

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