Checklist User Needs Review
Contents
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. |
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The user needs address all relevant stakeholders. |
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The user needs take all relevant use scenarios of the intended use into account. |
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The user needs cover all relevant categories (e.g. technical, regulatory, organizational, market). |
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The user needs are not ambiguous, self-contradicting or conflicting with each other. |
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The user needs are traceable. |
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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>\