Code Documentation for Traceability

Link code to requirements by embedding stable IDs like REQ-### and RISK-CTRL-### directly in code comments. This enforces traceability conventions for safety-related code, interfaces, and tests, simplifying regulatory compliance and impact analysis.

API documentation standards for traceability require documenting public interfaces with purpose, parameters, ranges, and error codes. This ensures clarity and brevity for safety-related code while maintaining comprehensive interface definitions.

Add traceability tags to code comments by including stable requirement IDs, such as writing // REQ-123: Implement safety interlock. This directly links implementations and modifications to external artifacts and risk controls for auditing.

No, you do not need to document change history in code comments for ISO 14971 risk management. The convention relies on the Version Control System (VCS) for change history, requiring only minimal necessary explanations and stable IDs in comments.

Traceability tagging in code comments is needed when implementing or modifying requirements, risk controls, safety-related code, interfaces, and tests. It ensures regulatory compliance and effective impact analysis during medical device development.