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Jira QMS: Can You Set Up a QMS And Requirements Management In Jira For Medical Device Compliance?

Dr. Oliver Eidel • QMS Software • Updated May 17, 2024 • Confluence QMS , Jira QMS

As a medical device manufacturer, can you set up your Quality Management System (QMS) in Jira? And can you manage your requirements (e.g. Design Inputs) there, too? The goal would be compliance with the ISO 13485, IEC 62304 and other standards required for medical device manufacturers. Watch my video to see how a setup in Jira could look like, and where you might run into problems if you get audited.

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Can We Integrate Our eQMS With Jira, GitHub, Sharepoint, etc.?

updated about 1 year ago

We'd like to integrate our eQMS with our development tools like e.g. Jira, GitHub, Sharepoint and others. Does that make sense and how should we set it up?

Dr. Oliver Eidel

Accepted answer

Don't do it, it doesn't make sense. Long Answer You're probably looking at eQMS software right now and are wondering which one of them integrates wel

Dr. Oliver Eidel

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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!