Medical device manufacturers have to comply with a set of regulations in order to get their products on the market. The process of regulatory compliance is both time- and resource demanding.

SoftComply aims to speed up the process of regulatory compliance by automating it and by integrating it to Atlassian Confluence and Jira.

SoftComply offers an affordable, FDA and MDR compliant Quality Management Solution on Atlassian ConfluenceCloud eQMS Solution.

SoftComply products that are included in the Cloud eQMS Solution for Confluence are the following:

  • SoftComply eQMS app on Confluence provides medical device developers with an FDA 21 CFR 820 and MDR compliant QMS content with embedded guidance on how to finalise all the documents in it. There are over 20 SOPs and over 70 technical document templates in the app.
  • SoftComply Static Snapshots app on Confluence to capture and freeze the always dynamic Confluence content before approving it.
  • SoftComply Change History app on Confluence to add a Document Change History Table to any page in Confluence for document approvals with timestamps.
Change History

Wish to Display Document Approval History on Confluence pages?

SoftComply Change History app captures document workflow history on your Confluence pages.

SoftComply eQMS

Looking for a Compliant Medical Device Quality Management System in Confluence?

SoftComply eQMS is a full Medical Device QMS developed as an app on Atlassian Confluence.

Cloud eQMS Solution

Looking for a Compliant Medical Device Quality Management System in Confluence?

SoftComply eQMS is a full Medical Device QMS developed as an app on Atlassian Confluence.

Static Snapshots

Wish to Capture and Freeze the Dynamic Content of Confluence?

SoftComply Static Snapshots is an Atlassian Confluence app for taking and storing content in a static form.