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 verifi…