design controls

[peter meijles]

Can JIRA be used for FDA regulated Design controls?

Can JIRA be used for Medical device product lifecycle management?

And if so could you provide information and examples

[Nic Brough [Adaptavist]]

Yes, it can be used for those. 

It's hard to give examples, because a couple of very vague generalised topics are a long way off anything resembling a representative use case.  Best we can do is tell you that there are a lot of organisations using it for both of those, and then ask for more detail.

[Matteo Gubellini [SoftComply]]

Hi Peter,

We have just released an eQMS plugin for Confluence with a full integrated quality system for Medical Devices. 

https://marketplace.atlassian.com/plugins/ee.softcomply.qms.confluence-blueprints/server/overview

It contains full guidance for FDA's 21 CFR compliance

Regards

Matteo