Don't know where to start? Watch our free starter videos and save lots of time and consultant fees

Templates IEC 62304 Templates

Updated June 9, 2022

Template: Checklist: Software Requirements Review

Dr. Oliver Eidel

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

docx

Download as PDF

pdf

Copy-paste to Google Docs

html

Download as Markdown

md

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!

Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

Template preview

Checklist: Software Requirements Review

Classes IEC 62304:2006 Section Document Section
A, B, C 5.2.6 (All)
ISO 13485:2016 Section Document Section
7.3.3 (All)
7.3.5 (All)

1. Summary

This checklist is used to review (verify) software requirements prior to implementation.

As with all regulatory documents, it’s more about the content than about the tool. You don’t have to fill this checklist out every time in Word / GDocs / etc., but could embed it in your Jira / GitHub workflow. The main point is that, at minimum, the items below should be filled out before you start implementing software requirements.

Feel free to add further rows in the checklist if they make sense for your company. This template is pretty much the bare minimum to be 62304-compliant.

2. Checklist

Software Requirements… Yes No Comment
are traceable to design input or risk control measures.      
are complete.      
are understandable, uniquely identifiable and do not contradict each other.      
include user interface requirements (mockups, wireframes, etc.), if relevant.      
include IT security requirements, if relevant.      
are testable and include acceptance criteria.      

3. Comments

<Insert comments if applicable>

4. Result

[ ] Software Requirements passed
[ ] Software Requirements not passed
[ ] Software 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.

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