OpenRegulatory Template

Stakeholder Requirements Review Checklist

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 Stakeholder Requirements.

Relevant documents:

2. Checklist

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).

3. Comments

<Insert comments if applicable>

4. Result

[ ] Stakeholder Requirements passed
[ ] Stakeholder Requirements not passed
[ ] Stakeholder Requirements passed with the following obligations: <Insert if applicable>


Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.