Most medical device companies need to have at least a compliant quality management system in place, not to mention the quality records that will always need to be generated during the lifecycle of the device.
Why Confluence?
With your software development team using Jira, it is natural that your organisation would like to have everything on Atlassian stack including your quality management documents. With the fantastic integration features between Jira and Confluence where you can pull information easily from one to the other using built in queries and macros, it is best to go with a quality management system in Confluence.
How to implement a compliant QMS in Confluence?
Following is a description of two options how you can have a compliant quality management system in Confluence:
1) For MDR/MDD (EU) compliance, you may opt to go with Confluence Cloud – affordable monthly payments are the best fit for medical device startups. Confluence cloud apps are also priced monthly and you could then add SoftComply eQMS with Comala Document Control apps for compliant quality management system and document approval workflows.
2) In the USA you will have to deal with FDA 21 CFR 11, much more demanding than the EU regulations. In this case, you need to have Confluence on Server as you have to show that you are in full control of your Confluence instance and this cannot be achieved with Atlassian cloud platform because there are frequent changes pushed on cloud products that users are not aware of beforehand. In addition, the limits that Atlassian imposes on Confluence cloud have an impact on certain aspects of the compliance.
An Incremental Process of Compliance
As a European medtech startup, you may opt to go for an incremental process of compliance:
If you plan to enter the EU market first, you can start with Confluence Cloud as its more affordable. You can then add SoftComply eQMS with Comala Document Control onto your Confluence Cloud instance.
Once you’ve decided to place your device to the US market, you may migrate to either Confluence Server or get an Atlassian partner host your Confluence instance and migrate from Comala Document Control to Comala Document Management and add Comala Publishing and Atlassian Crowd for full FDA 21 CFR 11 compliance.
To learn more about compliance features that are supported on Confluence Cloud vs Confluence Server, please keep reading.
