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design-review-facilitator

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Design review planning and execution skill for structured design phase gate reviews per 21 CFR 820.30

library/specializations/domains/science/biomedical-engineering/skills/design-review-facilitator/SKILL.md

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# 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
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