Planning, requirements analysis, architectural design, detailed design, unit implementation, integration, system testing, and release.
Testing the interfaces between modules.
This is the most extensive section of the checklist. It tracks the creation of technical documentation and verification evidence. IEC 62304 QMS Checklist for Medical Software Teams Iec 62304 Checklist Xls
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