Template: Checklist: User Needs Review

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then open the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you’re using a different QMS Software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don’t remove the copyright at the bottom).

Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you’re looking for step-by-step instructions for filling them out, check out our Wizard 🙂

Don't Miss Updates to This Template
Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview
ISO 13485:2016 SectionDocument Section
ClassesIEC 62304:2006 SectionDocument Section
A, B, C5.1.8(All)

1. Summary

With this checklist we verify the completeness and consistency of User Needs.

Relevant documents:

  • User Needs (Doc-ID)

2. Checklist

Checklist ItemsYesNoComment
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>

4. Result

[ ] User needs passed
[ ] User needs not passed
[ ] User needs 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.

Template preview


Leave the first comment