Iec 62304 Checklist Xls Jun 2026

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.

You should organize your rows by the five core process areas (Clauses 5–9): Process Area Key Checklist Items Development Iec 62304 Checklist Xls

5, 5.2, "Software requirements specification (SRS)", Requirements, "Document functional and non-functional S/W requirements traceable to system requirements", "SRS document, trace matrix", "All requirements uniquely identified and testable", Not Started, Systems Engineer, , , High, The checklist also proved invaluable during the Software

Here is an example of what an IEC 62304 checklist XLS might look like: | ... | 15

| Requirement ID (SRS) | Architecture Component | Software Unit | Test Case ID | Verification Status | |----------------------|------------------------|---------------|--------------|----------------------| | REQ-1 | Arch-1 | Unit-1.1 | TC-01 | Pass | | ... | ... | ... | ... | ... |

15, 8.1, "Configuration management plan", CM, "Establish CM for software items: baselines, versioning, build control", "CM Plan, baselined repository", "Source, deliverables, and baselines controlled", Not Started, CM Manager, , , High,