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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
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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How Can We Set Up a QMS in Confluence / Jira?

Anonymous
about 2 years ago
We’re already using Confluence and Jira for our development planning. Now we need to set up a Quality Management System (QMS) for medical device compliance (e.g. ISO 13485). Can we set up that QMS in
Accepted 1 answer

Don’t do it. Jira sucks, and Confluence sucks, too. I don’t see how any rational human could choose these tools for daily use unless being blackmailed

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Updated over 1 year ago

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Dr. Oliver Eidel

updated over 1 year ago
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

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