Iec 62304 Checklist Xls ^hot^ File

Are SOUP items identified with version numbers and manufacturers? Applicability: Classes A, B, C.

As they progressed through the project, the checklist helped Maria's team to:

Optional additional sheets:

40, 23.1, "Record of decisions and rationale", Documentation, "Maintain decision logs for safety-critical design choices", "Decision log, meeting minutes", "Rationales traceable and auditable", Not Started, Project Manager, , , Medium,

(Dropdown: Pass, Fail, N/A, In Progress). Iec 62304 Checklist Xls

: Use Excel's conditional formatting. Set "Non-Compliant" cells to turn red and "Compliant" cells to turn green. This provides a quick visual indicator of project readiness.

If you are developing medical device software, you have likely encountered IEC 62304 — the internationally recognised standard that defines the software life cycle processes for medical devices. Whether you are navigating your first regulatory submission or preparing for an audit, one question inevitably arises: how do you track compliance efficiently? Are SOUP items identified with version numbers and

Non-serious injury is possible. The software can lead to a hazardous situation even after risk control measures, but the harm is not severe. Class B requires a defined lifecycle with requirements, architecture, detailed design, unit testing, integration testing, and system testing, with risk management linked to design.

To build an efficient tracking sheet, set up your Excel workbook with the following column headers: : Use Excel's conditional formatting

A typical IEC 62304 checklist XLS may include the following sections: