| ISO 13485:2016 Section | Document Section |
|---|---|
| 7.3.2 | (All) |
| Classes | IEC 62304:2006 Section | Document Section |
|---|---|---|
| A, B, C | 5.1.8 | (All) |
1. Overview
This checklist is intended to ensure that user needs are complete and consistent.
Key documents involved:
- User Needs (Document ID)
2. Checklist
| Checklist Items | Yes | No | Comment |
|---|---|---|---|
| User needs are comprehensive and complete. | |||
| User needs address the requirements of all relevant stakeholders. | |||
| User needs incorporate all relevant use cases for the intended purpose. | |||
| User needs include all necessary categories (e.g., technical, regulatory, organizational, market). | |||
| User needs are clear, non-contradictory, and do not conflict with one another. | |||
| User needs are traceable. | |||
| User needs are verifiable through testing (if applicable). |
3. Comments
\
4. Review Outcome
[ ] User needs approved\
[ ] User needs not approved\
[ ] User needs approved with the following conditions: \