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Software List

Dr. Oliver Eidel · ISO 13485 Templates · Published June 09, 2022

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This is a free template, provided by OpenRegulatory. If you are a user of Formwork, our eQMS software, you can save time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

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Related

Checklist: Software Release

Checklist: Software Release

Dr. Oliver Eidel

updated about 2 years ago
A

Software Validation Procedure for ISO 13485 compliance?

Anonymous
about 2 years ago
We’re currently using GitHub for our code repositories. Now we’ve heard that this sort of software needs to be “validated”. What does that mean? Do we have to write tests for it? Do we need to self-ho
Accepted 1 answer

Don’t panic :) Yes, you have to validate software and it feels like overhead, but it’s manageable and not a huge effort. Write down your intended use

Checklist: Software Requirements Review

Checklist: Software Requirements Review

Dr. Oliver Eidel

updated about 2 years ago
Template preview

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

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