OpenRegulatory
Product Templates Learn Wizard Consulting
⌘J Log in Get started for free
Learn ›

Tag: OTS Software

Articles

No articles yet.

Questions

A

How to document SOUP for IEC 62304 compliance?

Anonymous
updated about 1 year ago
Our python backend contains lots of dependencies, for example flask and the requests library. According to the IEC 62304, third-party dependencies are “SOUP” and must be documented. We have no idea ho
Dr. Oliver Eidel

Accepted answer

You need to create a list of your dependencies. That list can be a spreadsheet, a markdown file, or pretty much anything else which you can save as do

Videos

No videos yet.

Templates

Document Template
Dr. Oliver Eidel

SOUP List (Software of Unknown Provenance)

Dr. Oliver Eidel
updated about 1 year ago

OpenRegulatory Network

Digital Health Jobs Better EUDAMED EUDAMED Burn Conference 2021

Making Compliance Transparent

The Wizard Regulatory Strategy Workshop QMS Software Reviews Notified Body Reviews Community

QMS Software

QMS Software For Medical Devices Greenlight Guru vs. Qualio Greenlight Guru Price Qualio Price
OpenRegulatory
About Join Us Support Us Template License Privacy Policy Imprint

© 2025 OpenReg GmbH. All rights reserved.

If you have to explain git to your consultant, you should probably get a new consultant.