Templates IEC 62304 Templates

Updated December 2, 2022

Template: Software Architecture Checklist

Sven Piechottka

Template Download

This is a free template, provided by OpenRegulatory.

You can download it 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

Software Architecture Checklist

Regulatory references:

IEC 62304, para. 5.3.6 [class B, C]

Relevant other documentation:

1. Checklist

Criteria Pass / Fail
The software architecture is in agreement with the software requirements. ( ) Yes
( ) Improve:
All software systems are listed and their respective safety class is stated. ( ) Yes
( ) Improve:
All software components are listed and described, including interfaces. ( ) Yes
( ) Improve:
All software units are listed and described. ( ) Yes
( ) Improve:
(Optional) Further architecture is described, e.g. databases, security and data protection requirements. ( ) Yes
( ) Improve:
The software architecture can be implemented with our given resources. ( ) Yes
( ) Improve:


<Insert comments if applicable>

3. Results

( ) Software Architecture passed
( ) Software Architecture not passed
( ) Software Architecture 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.

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