40, 23.1, "Record of decisions and rationale", Documentation, "Maintain decision logs for safety-critical design choices", "Decision log, meeting minutes", "Rationales traceable and auditable", Not Started, Project Manager, , , Medium,
| Clause | Activity | Class A | Class B | Class C | Status | Reference to ISO 14971 | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Identify hazardous situations | ✔ | ✔ | ✔ | | Hazard log | | | 6.1 | Risk control measures in software | ✔ | ✔ | ✔ | | Risk control spec | | | 6.2 | Verify risk controls | ✔ | ✔ | ✔ | | Verification report | | | 6.3 | Risk management of software changes | ✔ | ✔ | ✔ | | Change impact analysis | | | 6.4 | Residual risk evaluation | ✔ | ✔ | ✔ | | Residual risk report | | | 6.5 | Risk-benefit analysis (if needed) | ✘ | ✔ | ✔ | | Risk-benefit doc | | Iec 62304 Checklist Xls
| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | M1 | 6.1 | Is there a process for receiving feedback? | How are post-market issues fed back into dev? | Complaint Handling SOP | | M2 | 6.2 | Are problem reports analyzed? | Assess impact on safety and determine classification. | Problem Report Analysis | | C1 | 8.1 | Is a Configuration Management Plan in place? | How is version control, branching, and merging handled? | CM Plan | | C2 | 8.2 | Are change records maintained? | Who made the change, when, and why? | Version Control Logs | | C3 | 8.3 | Is configuration status accounting performed? | Can you identify the exact configuration of any released version? | Release Manifests | 40, 23
I hope this helps! Let me know if you'd like me to expand on any section. | Assess impact on safety and determine classification