Fix — Iec 62304 Checklist Xls

The Medical Device Software Conundrum

35, 19.1, "Audit and internal review", Quality, "Plan and perform internal audits of software lifecycle processes", "Audit schedule, audit reports, corrective actions", "Findings closed within target", Not Started, QA Lead, , , Medium, Iec 62304 Checklist Xls

4. Step 3: The Master Checklist (Excel Data Structure)

This is the core content for the spreadsheet. It outlines the specific activities required by the standard. The Medical Device Software Conundrum 35, 19

• [ ] 5.2.1 – Are all software requirements documented?
• [ ] 5.2.2 – Are requirements prioritized for safety?
• [ ] 5.2.3 – Are risks (Hazards) linked to specific requirements?
• Common Audit Finding: Missing traceability from Hazard to Requirement. Fix: Add a "Risk ID" column to your XLS.

41, 24.1, "Clinical evaluation inputs", Clinical, "Include clinical input where software affects clinical decisions", "Clinical evaluation report or literature review", "Clinical risks assessed", Not Started, Clinical Lead, , , High, [ ] 5

• IEC 62304 Medical Device Software Standard
• Medical Device Software Development and IEC 62304