| | Requirement | Activity | Status | | --- | --- | --- | --- | | 5.1.1 | Software development planning | Create a software development plan | | | 5.1.2 | Software design | Create a software design document | | | 5.2.1 | Risk analysis | Perform a risk analysis | | | 5.3.1 | Verification and validation planning | Create a verification and validation plan | |
Your checklist must account for these classes, as the required activities increase in rigor from Class A to Class C. IEC 62304: Medical Device Software Life Cycle Processes 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, | | Requirement | Activity | Status |
