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