design-review-facilitator

# Design Review Facilitator Skill ## Purpose The Design Review Facilitator Skill supports planning and execution of structured design phase gate reviews for medical devices, ensuring compliance with 21 CFR 820.30 and effective cross-functional evaluation. ## Capabilities - Design review agenda generation - Review checklist by phase (input, output, verification, validation, transfer) - Action item tracking - Review record documentation - Cross-functional reviewer identification - Risk review integration - Design stage gate criteria definition - Review meeting facilitation support - Decision documentation templates - Follow-up tracking automation - Review metrics and trending ## Usage Guidelines ### When to Use - Planning design phase gate reviews - Conducting formal design reviews - Documenting review outcomes - Tracking design review action items ### Prerequisites - Design phase deliverables prepared - Review team identified - Review criteria established - Risk management updates available ### Best Practices - Include all required functions in reviews - Document all decisions and rationale - Track action items to closure - Integrate risk review at each phase gate ## Process Integration This skill integrates with the following processes: - Design Control Process Implementation - Verification and Validation Test Planning - Design for Manufacturing and Assembly (DFMA) - Medical Device Risk Management (ISO 14971) ## Dependencies - Design documentation systems - Meetin...