| Classes | IEC 62304:2006 Section | Document Section |
|---|---|---|
| A, B, C | 5.2.6 | (All) |
| ISO 13485:2016 Section | Document Section |
|---|---|
| 7.3.3 | (All) |
| 7.3.5 | (All) |
1. Overview
This checklist is designed to verify and review software requirements prior to their implementation.
Like all regulatory documentation, the focus should be on content rather than format. It’s not necessary to complete this checklist in Word, Google Docs, or similar; it can be integrated into workflows such as Jira or GitHub. The key is that the items listed below should be addressed and documented before beginning the implementation of software requirements.
Additional rows can be added to this checklist if needed to suit your company’s specific needs. This template provides the minimum required for compliance with IEC 62304.
2. Checklist
| Software Requirements… | Yes | No | Comment |
|---|---|---|---|
| are traceable to design inputs or risk control measures. | |||
| are complete. | |||
| are clear, uniquely identifiable, and free of contradictions. | |||
| include user interface requirements (e.g., mockups, wireframes), if applicable. | |||
| include IT security requirements, if applicable. | |||
| are testable and include defined acceptance criteria. |
3. Comments
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4. Review Outcome
[ ] Software Requirements approved\
[ ] Software Requirements not approved\
[ ] Software Requirements approved with the following conditions: \