dhf design history file

has anyone used confluence/JIRA in a regulated environment i.e. FDA/ISO

2 answers

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Hello Arnold, did you get the answer to your question? I have the same challenge and haven't found the best option.

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Hi Arnold,

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

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