Individual skill
requirements-traceability-manager
Design control traceability skill for managing user needs, design inputs, design outputs, and verification/validation linkages
library/specializations/domains/science/biomedical-engineering/skills/requirements-traceability-manager/SKILL.md
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# Requirements Traceability Manager Skill
## Purpose
The Requirements Traceability Manager Skill ensures comprehensive traceability throughout the medical device design control process, linking user needs to design inputs, design outputs, and verification/validation activities per 21 CFR 820.30.
## Capabilities
- Bidirectional traceability matrix generation
- Requirements coverage analysis
- Gap identification in V&V coverage
- Design change impact analysis
- Traceability report generation
- DHF (Design History File) completeness checking