| ISO 13485:2016 Section | Document Section |
|---|---|
| 7.3.2 | (Al) |
| Classes | IEC 62304:2006 Section | Document Section |
|---|---|---|
| A, B, C | 5.1.8 | (All) |
With this checklist we verify the completeness and consistency of Stakeholder Requirements.
Relevant documents:
| Checklist Items | Yes | No | Comment |
|---|---|---|---|
| The stakeholder requirements are complete. | |||
| The stakeholder requirements address all relevant stakeholders. | |||
| The stakeholder requirements take all relevant use scenarios of the intended use into account. | |||
| The stakeholder requirements cover all relevant categories (e.g. technical, regulatory, organizational, market). | |||
| The stakeholder requirements are not ambiguous, self-contradicting or conflicting with each other. | |||
| The stakeholder requirements are traceable. | |||
| The stakeholder requirements are testable (if required). |
<Insert comments if applicable>
[ ] Stakeholder Requirements passed
[ ] Stakeholder Requirements not passed
[ ] Stakeholder Requirements passed with the following obligations:
<Insert if applicable>
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