View the talks from the OpenRegulatory Conference 2021!

Updated September 30, 2021

Template: Checklist: Software Requirements Review

Dr. Oliver Eidel
IEC 62304

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

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

Download as:

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.
Beginning of template

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)


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

As with all regulatory documents, it’s more about then 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 tepmlate is pretty much the bare minimum to be 62304-compliant.


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.      

Template Copyright See template license.

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

End of template


Regulatory compliance is not rocket science.

But finding a good consultant is.

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.