Iec 62304 Checklist Xls ((free))

This is a structured IEC 62304:2006+AMD1:2015 checklist guide, formatted for easy translation into an Excel (.xls/.xlsx) workbook.

I have organized this into 5 main sheets within a single Excel file. Iec 62304 Checklist Xls

Sheet 1: Legend & Metadata

Use this sheet to define your project, risk class, and color coding. Sheet 1: Legend & Metadata Use this sheet

| 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 | Tab 6: Integration & Integration Testing (Clause 5

Tab 6: Integration & Integration Testing (Clause 5.5)

Testing the interfaces between modules.

• [ ] 5.5.1 – Is there an Integration Test Plan?
• [ ] 5.5.2 – Are tested components tracked (Version control hash)?
• [ ] 5.5.3 – Are failed integration tests documented in Problem Resolution system?

Tab 3: Software Requirements Analysis (Clause 5.2)

Requirements must be uniquely identifiable, testable, and traceable to Risk Management (ISO 14971).

• [ ] 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.