Create compliance mapping pages for ISO 13485 medical device QMS, ISO 14971 risk management, IEC 62304 software lifecycle, IEC 82304-1 health software safety, and IEC 62366 usability engineering.
Acceptance Criteria:
- Pages exist in
/Compliance/.
- Each standard’s clauses mapped to quality activities.
- Links established to existing or placeholder SOPs/WIs.
Create compliance mapping pages for ISO 13485 medical device QMS, ISO 14971 risk management, IEC 62304 software lifecycle, IEC 82304-1 health software safety, and IEC 62366 usability engineering.
Acceptance Criteria:
/Compliance/.