Checklist User Needs Review
|ISO 13485:2016 Section||Document Section|
|Classes||IEC 62304:2006 Section||Document Section|
|A, B, C||5.1.8||(All)|
With this checklist we verify the completeness and consistency of User Needs.
- User Needs (Doc-ID)
|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).|
<Insert comments if applicable>
[ ] User needs passed
[ ] User needs not passed
[ ] User needs passed with the following obligations: <Insert if applicable>\
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