| name | design-review-facilitator |
| description | Design review planning and execution skill for structured design phase gate reviews per 21 CFR 820.30 |
| allowed-tools | ["Read","Write","Glob","Grep","Edit","Bash"] |
| metadata | {"specialization":"biomedical-engineering","domain":"science","category":"Design Control","skill-id":"BME-SK-006"} |
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
- Meeting management tools
- Action item tracking systems
- Risk management databases
- Review templates per FDA guidance
Configuration
design-review-facilitator:
review-phases:
- design-input-review
- design-output-review
- verification-review
- validation-review
- design-transfer-review
required-functions:
- engineering
- quality
- regulatory
- manufacturing
- clinical
decision-types:
- approved
- approved-with-conditions
- not-approved
Output Artifacts
- Design review agendas
- Phase-specific checklists
- Review meeting minutes
- Action item logs
- Decision records
- Review summary reports
- Attendance records
- Follow-up status reports
Quality Criteria
- All required functions participate in reviews
- Review records meet 21 CFR 820.30 requirements
- Action items tracked to closure
- Decisions clearly documented with rationale
- Risk considerations integrated
- Phase gate criteria objectively assessed
