Hiring or looking for a job in Digital Health? Check out our Digital Health Jobs board

Templates IEC 62304 Templates

Updated June 27, 2022

Template: User Needs List

Sven Piechottka

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).

Download as Word File


Download as PDF


Copy-paste to Google Docs


Download as Markdown


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

User Needs List

This is a list of your user needs (also referred to as “stakeholder requirements”). This is what you would most commonly start with for your requirements mapping: it is the most high-level part of your design input. Describe the generic requirements your device will need to meet. Only in a next step, these user needs will be translated into (and linked to) software requirements which will present the technical specifications of your product.

Of course, you could also use your own tool like Jira or GitHub issues for this. Just ensure that the content (i.e. the columns shown here) is roughly the same.

Mapping of Standard Requirements to Document Sections

ISO 13485:2016 Section Document Section
7.2.1 (All)
7.3.3 (All)
IEC 62366-1:2015 Section Title Document Section
5.2 Identify user interface characteristics related to safety and potential use errors 1
5.6 Establish user interface specification 1

1. User Needs

Your user needs should typically take into account:

User Need ID User Group Requirement Description Safety-Critical?
1 User The software returns a score predicting Covid contraction based on (…). Yes
2 User Users can read the instructions for use or contact support in case of questions. Yes
3 Company The software can be integrated with most laboratory systems in the intended use environment. No
4 Regulatory authorities The device is developed in compliance with applicable regulations, norms and standards (e.g. IVDR / MDR, GDPR, HIPAA). No
5 (…) (…) (…)

Template Copyright openregulatory.com. See template license.

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

Template Copyright openregulatory.com. See template license.

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

No QMS on this planet will save you from creating crappy software.