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:
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Build design verification units
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Conduct design verification testing:
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Reliability
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Biocompatibility
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Accelerated aging
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Sterilization
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Performance
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Packaging evaluation
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Build design validation units
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Conduct design validation testing
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Update Risk Management Plan
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Prepare and submit regulatory submissions
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Phase Review
Deliverables:
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Design verification and validation protocol(s)
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Design verification and validation units
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Design verification and validation test reports
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Shelf-life expiration dating
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Regulatory submissions and approvals