Iec 62304 Checklist Xls ((exclusive)) 🚀

The intensity of documentation required by IEC 62304 depends on the (Class A, B, or C), which is determined by the severity of potential harm, as outlined in ISO 14971. Class A: No injury or damage to health. Class B: Non-serious injury. Class C: Death or serious injury.

Configuration management ensures your code, tools, and documentation are controlled and reproducible.

Referencing document names that change over time. Use fixed document IDs (e.g., SRS-01 ) rather than volatile file names (e.g., Software_Requirements_Final_v3.docx ).

Before beginning the checklist, the Safety Class must be determined according to Clause 4.3. Iec 62304 Checklist Xls

A robust Excel checklist based on IEC 62304 should cover the following core sections, aligned with the standard's clauses: 1. Software Development Planning

Specifically analyzing the risks associated with Software of Unknown Provenance (e.g., third-party libraries, open-source code, or commercial operating systems). 4. Clause 8: Software Configuration Management Process

Do the detailed designs ensure safety-related requirements are met? The intensity of documentation required by IEC 62304

This module tracks how bugs, anomalies, and customer complaints are investigated and resolved.

Gaps in traceability are among the most common audit findings. Your checklist should explicitly verify bidirectional traceability throughout the V-model.

IEC 62304 explicitly demands bidirectional traceability between software requirements, system requirements, risk control measures, and verification tests. Excel’s tabular format simplifies this mapping. Class C: Death or serious injury

A robust IEC 62304 checklist should be organized by the key processes outlined in the standard (Clauses 4-9). 1. Software Development Planning (Clause 5.1)

Quickly identify which clauses lack corresponding standard operating procedures (SOPs) or artifacts.

The specific team member or role assigned to execute and verify the clause.

Are hazardous situations caused by SOUP (Software of Unknown Provenance) evaluated? Applicability: Classes B, C only.

Do not wait until the end of the project to fill out the checklist. Use it throughout the development life cycle. Conclusion