Iec 62304 Checklist Xls Patched Site

| | 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 | |

The checklist also proved invaluable during the Software Configuration Management and Software Problem Resolution processes. It provided a structured way to track changes, manage versions, and document the resolution of any issues that arose during development. Iec 62304 Checklist Xls

Define functional, performance, and safety requirements. | | Requirement | Activity | Status |

Planning, requirements analysis, architectural design, implementation, and system testing. Software Maintenance Process (Clause 6): and safety requirements.