Requirements Traceability

Bidirectional traceability links medical device software requirements, hazards, design, code, tests, and anomalies across all lifecycle phases. It ensures every artifact is connected, providing a clear audit trail and enabling thorough impact analysis to prevent oversight.

You can generate a traceability matrix by enforcing stable ID schemas for all artifacts and using automation support. This links requirements to hazards, design, code, tests, and anomalies, ensuring IEC 62304 compliance through complete artifact tracking.

Verify test case links by applying bidirectional traceability across all lifecycle phases and integrating CI checks for missing links. This automation detects gaps, ensuring every test case corresponds directly to a safety requirement.

Yes, stable ID schemas are required for CI integration and missing link detection. Consistent identifiers for all artifacts enable automated traceability matrix generation and reliable impact analysis during continuous integration.

Yes, when a new safety requirement is added, bidirectional traceability helps perform impact analysis by verifying corresponding design elements, code changes, and test cases are updated and linked, preventing oversight across the software lifecycle.

The best way to enforce traceability for ISO 14971 hazard analysis is maintaining bidirectional links between hazards, requirements, design, and tests. This ensures complete audit trails and prevents unmitigated hazards in medical device software.