Come for the products,
stay for the community

The Atlassian Community can help you and your team get more value out of Atlassian products and practices.

Atlassian Community about banner
Community Members
Community Events
Community Groups

Systems validation according to Regulation (EU) 2017/746

As part of the Regulatory department at a medical device manufacturing company and according to  Regulation (EU) 2017/746 we are required to validate the systems we daily use during the company's product development.


I wondered if besides the technical information I have found based on the cloud's security compliance of the cloud there would be any kind of information/documentation Atlassian would be able to share to facilitate the PQ/OQ/IQ validation we are planning on carrying out on our own.


Thank you!

1 answer

1 vote

We have not yet evaluated for EU 2017/746, however, we recently aligned our practices with HIPAA, which is a US medical data framework. It might be similar enough to help with your evaluation. Please see : 

Suggest an answer

Log in or Sign up to answer
Community showcase
Published in Jira Software

Upcoming changes to epic fields in company-managed projects

👋 Hi there Jira Community! A few months ago we shared with you plans around renaming epics in your company-managed projects. As part of these changes, we highlighted upcoming changes to epics on...

14,840 views 37 48
Read article

Community Events

Connect with like-minded Atlassian users at free events near you!

Find an event

Connect with like-minded Atlassian users at free events near you!

Unfortunately there are no Community Events near you at the moment.

Host an event

You're one step closer to meeting fellow Atlassian users at your local event. Learn more about Community Events

Events near you