Iec 62304 Checklist Xls _hot_ Jun 2026

| Column A | Column B | Column C | | :--- | :--- | :--- | | | 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 |

Use the spreadsheet to create a Traceability Matrix (Requirement -> Design -> Code -> Test). Iec 62304 Checklist Xls

Have software items contributing to hazardous situations been identified? Are risk mitigation measures implemented via software requirements? Have hazardous situations stemming from SOUP been evaluated? 5. Software Configuration Management Process (Clause 8) | Column A | Column B | Column

Document specific software units (Class C only). Have hazardous situations stemming from SOUP been evaluated

IEC 62304 comprises several key components, including: