This is the heart of the standard. For each safety class, your checklist must verify:
Includes plans for development, verification, and risk management.
"Who deleted the 1.0.4 branch?" she muttered. The XLS file didn't care about office drama. It required a rigorous trace of every line of code, every change, and every "oops" ever committed to the repository. The SOUP Incident By mid-afternoon, Sarah hit the dreaded SOUP section Iec 62304 Checklist Xls
Use Excel’s conditional formatting to turn the entire row if:
IEC 62304 is an international standard for medical device software, published by the International Electrotechnical Commission (IEC). The standard provides a framework for ensuring the safety and effectiveness of medical device software, and is widely adopted by medical device manufacturers and developers. IEC 62304 covers a range of topics, including: This is the heart of the standard
For , your checklist must include a “Release Approval” tab that re-evaluates Clauses 5.7 (Release) and 9.6 (Field actions) before every pipeline deployment.
You can build your own from scratch (approx. 8-12 hours of work), or download an industry-tested template. When evaluating a pre-made XLS, ensure it includes: The XLS file didn't care about office drama
The depth of documentation required depends on the : Class A: No injury or damage to health is possible. Class B: Non-serious injury is possible. Class C: Death or serious injury is possible. IEC 62304:2006/AMD1:2015 Checklist .xls file attached
=AND(D2="Class B", E2="Missing", TODAY()>F2-30) → Fill cell red.