62304 Checklist Xls: Iec

The Medical Device Software Conundrum

VitalPath’s cardiac monitor received its certification, and soon, it was being used in hospitals around the world. Elias and his team knew that their success wasn't just due to their technical brilliance, but also to the humble spreadsheet that had guided them through the complexities of IEC 62304. Iec 62304 Checklist Xls

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Failure #2: Forgetting Class C Specifics Open Excel → New Workbook

When the auditors arrived, they didn't see a stressed-out team hunting for files. Sarah simply opened her IEC 62304 Checklist XLS assessing impact of changes

How to use this as an XLS file

1. Open Excel → New Workbook.
2. Rename Sheet1 to Legend.
3. Rename Sheet2 to Dev_Process.
4. Rename Sheet3 to Risk_Mgmt.
5. Rename Sheet4 to V_and_V.
6. Rename Sheet5 to Traceability.
7. Copy the tables above into the respective sheets.
8. Apply conditional formatting for Status column:

   Establish procedures for tracking bugs, assessing impact of changes, and re-validating modified code. Software Risk Management (Clause 7):