Design Verification & Validation

PHASE 1

Concept
Generation

PHASE 2

Proof of
Concept

PHASE 3

Product Design &
Process Development

PHASE 4

Design Verification
& Validation

PHASE 5

Process Installation
& Optimization

PHASE 6

Process Validation &
manufactoring transfer

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
 

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