Iec 62304 Checklist Xls -

Managing configuration items and controlling changes to the software system. Software Problem Resolution (Clause 9):

| Requirement ID | Requirement Text | Risk Control? (Y/N) | Design Element | Code Module(s) | Unit Test ID | System Test ID | Status | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | REQ-1 | [e.g., Device powers on] | N | ARCH-1.2 | main.c | UT-01 | ST-01 | DONE | | REQ-2 | [e.g., Alarm triggers within 1s] | Y (Risk #12) | ARCH-3.1 | alarm.c | UT-08 | ST-11 | IN PROGRESS | | REQ-3 | ... | ... | ... | ... | ... | ... | ... | Iec 62304 Checklist Xls