Early access registrations are open for Headstart, a predictable, fixed-price program for becoming compliant.

Updated July 27, 2021

Template: SOUP List (Software of Unknown Provenance)

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 articles

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

SOUP List (Software of Unknown Provenance)

The 62304 requires you to document your SOUP, which is short for Software of Unknown Provenance. In human language, those are the third-party libraries you’re using in your code, typically in your requirements.txt or Gemfile.

Classes IEC 62304:2006 Section Document Section
B, C 5.3.3 (Functional and Performance Requirements) 2
B, C 5.3.4 (Hardware and Software Requirements) 2
B, C 7.1.2 (Hazardous Situations) 2
B, C 7.1.3 (SOUP Anomaly Lists) 2
A, B, C 8.1.2 (Identify SOUP) 2

1 Risk Level Definitions

The 62304 requires you to assess risks associated with SOUP. The simplest way to do this is to classify each SOUP as a certain risk level. Unless you’re developing software which shoots radiation at patients, it’s likely that your SOUP risk levels remain “low” or “medium”.

Risk Level Definition
Low Malfunction in SOUP can’t lead to patient harm.
Medium Malfunction in SOUP can lead to reversible patient harm.
High Malfunction in SOUP can lead to irreversible patient harm.

2 SOUP List

This is the actual SOUP list. For each third-party library you use, add an entry in the table below. The idea is to only have one “global” SOUP list for your medical device even though the code may actually live in multiple repositories. That’s what the “software system” column is for; you could also mention your (git) repository there.

When specifying requirements, the 62304 requires you to mention functional, performance, hard- and software requirements. However, you may not have to re-state certain requirements if they apply to all SOUP, e.g. “runs on linux”. So prefer to keep the requirements simple, in a way in which you would communicate it to colleages on your development team when answering the question “why did we import this library?”.

As with all templates: It’s more about the content (i.e. the columns you see below) than the tool (filling this out in google sheets / markdown / wherever). Nobody says that you have to maintain this as a google sheet. If you can find a way to integrate this in your workflow in a better way, e.g. in a markdown file in your git repository, go for it! Just keep in mind that you need to be able to export it to send it to auditors.

ID Software System Package Name Programming Language Version Website Last verified at Risk Level Requirements Verification Reasoning
1 Mobile App react-native JavaScript 0.61 Link 23.10.2020 Low * Runs JS on Android / iOS Commonly used, maintained by large organisation, sufficient test coverage

Template Copyright openregulatory.com. See template license.

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

End of template

Questions?

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.