Template: Software List

Dr. Oliver Eidel • ISO 13485 Templates • Published June 09, 2022 • Software Validation

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Software List

List all your software which you use either in your Quality Management System or as part of your product
development. Typically, those include Slack, GitHub, your IDE (e.g., IntelliJ) and programming libraries
which you (only) use during development.

Libraries which you include in your product (i.e., which are deployed with it) don't belong here. They belong
in the SOUP list.

ID	Name	Manufacturer	Bug tracker URL	Needs validation?	Next validation	Last validation	Decommissioning
1	GitHub	GitHub, Inc.		yes	2020-05-17
2	IntelliJ IDEA	JetBrains s.r.o.	https://youtrack.jetbrains.com/issues/IDEA	yes	2020-05-17

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Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you’re still lost and have further questions, reach out any time!

More about me

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Lost In Regulation? We're here to help.

SOUP List (Software of Unknown Provenance)

Software Development and Maintenance Plan

IEC 62304:2006 Mapping of Requirements to Documents

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Software List

Dr. Oliver Eidel