Some related articles:
Identifying configuration items, version control, change control, and configuration audits. Problem Resolution Iec 62304 Checklist Xls
19, 9.1, "Risk management integration", Risk, "Integrate ISO 14971-based risk management with software lifecycle", "Risk management plan, risk file (hazards, mitigations, residual risk)", "Risks identified, controls implemented and verified", Not Started, Risk Manager, , , High, Some related articles: Identifying configuration items