!!hot!! - Iec 62304 Checklist Xls

I can provide targeted advice or map out a specific clause structure based on your setup.

What is the (Class A, B, or C) of your medical device?

If you want to tailor this framework to your current medical device project, tell me:

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Once you have established your baseline checklist, consider automation to reduce manual effort:

If you are preparing for an audit, I can help you that automate this checklist process, or compare the requirements for Class B versus Class C software . Share public link

The standard has 90+ requirements depending on the Software Safety Class ( I can provide targeted advice or map out

Are software anomalies recorded with enough detail to reproduce the issue? Applicability: Classes A, B, C.

Create tabs for each lifecycle phase:

For classes B and C, include a dedicated sheet for Software of Unknown Provenance (SOUP) listing each third-party library with columns for: This is a specialized topic about medical device

This section ensures that a plan is in place to guide development. Is there a Software Development Plan (SDP)?

The exact document ID and section number where proof of compliance resides (e.g., SRS-004, Ver 2.0 ).

Identify software faults that could cause a hazard.

—maintenance no longer includes new features, only defect fixes and adaptations.

Implement a formal pull request, review, and approval process before changing code. Module 9: Software Problem Resolution Process