requirements-traceability-manager

# 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 - User needs to design input mapping - Design output to verification linking - Risk control to requirements tracing - Regulatory requirement coverage tracking - Orphan requirement identification ## Usage Guidelines ### When to Use - Establishing design control traceability - Conducting V&V coverage analysis - Assessing design change impacts - Preparing for regulatory audits ### Prerequisites - User needs documented - Design inputs established - Design outputs defined - V&V protocols available ### Best Practices - Establish traceability from project inception - Update matrices with every design change - Verify bidirectional completeness regularly - Integrate with requirements management tools ## Process Integration This skill integrates with the following processes: - Design Control Process Implementation - Verification and Validation Test Planning - Software Development Lifecycle (IEC 62304) - Medical Device Risk Management (ISO 14...