The IEC 62304 Checklist is a structural tool used to ensure medical device software life cycle processes meet international standards for safety and compliance. It maps specific regulatory requirements to the documentation and activities required for different software safety classes. Core Components of an IEC 62304 Checklist
14, 7.2, "Problem resolution and tracking", Maintenance, "Record, investigate, and resolve software anomalies", "Issue tracking system, CAPA records", "All issues logged and dispositioned", Not Started, Support Lead, , , Medium, Iec 62304 Checklist Xls
The spreadsheet was Sarah's secret weapon. It wasn’t just a simple list of tasks; it was a roadmap, a meticulously crafted guide that translated the dense language of the standard into actionable steps. The IEC 62304 Checklist is a structural tool
Problem Resolution (Clause 9): Document a process for investigating and resolving anomalies. Software Safety Classifications Risk Management :
| Column A | Column B | Column C |
| :--- | :--- | :--- |
| Item | Value | Instructions |
| Medical Device Name | [Enter Name] | |
| Software Version | [Enter Version] | |
| IEC 62304 Class | A, B, or C | Select one |
| Safety Classification | `` | Per ISO 14971 |
| Document Owner | [Name] | |
| Last Review Date | [Date] | |
| Status Key | | |
| NOT STARTED | Red background | No activity |
| IN PROGRESS | Yellow background | Partially complete |
| DONE | Green background | Evidence exists |
| N/A | Gray background | Not required for this class |
