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Why Medical Device Startups Need Electronic Document Management Systems (And How to Build One in Confluence)

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Marion Lepmets

CEO
October 24, 2025

If you’re developing a medical device, you must prove that it is safe and effective. That proof lives in your documents: your procedures, design records, risk assessments, and test reports. Managing those documents properly is called “document control”. At first, this might sound like an administrative detail — a few…

Controlled Docs Startup Journey

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Marion Lepmets

CEO
May 10, 2023

Introducing the Toolbox App that Solves Three Critical Problems for Confluence Cloud Users Are you a Confluence user who has experienced the frustration of not being able to display page information in the body of a page, create static links to specific versions of pages, or delete pages and their...

RAID risk framework in Jira
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Marion Lepmets

CEO
May 10, 2023
Why should you use the RAID risk framework and how to manage your RAID log in Jira with the help of the SoftComply Risk Manager Plus....
On Regulated on Atlassian Cloud
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Marion Lepmets

CEO
April 24, 2023

Introduction Companies in the regulated industries like medical device, space and aviation and other complex system developers are among the latest adopters of Atlassian Cloud as their collaboration and product lifecycle development platform. In addition to industry-specific regulations, companies in the regulated industries are periodically audited also in the areas...

Risk Management Jira
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Marion Lepmets

CEO
March 27, 2023

The SoftComply Risk Manager Plus on Jira Cloud is the most comprehensive risk management app in Jira. With the SoftComply Risk Manager Plus app, you can: Quick Filters in the Risk Table View The Risk Manager Plus app’s Risk Table view now has Quick Filters that you can access from...

ValidationConfluence
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Marion Lepmets

CEO
March 21, 2023
What to validate in your Confluence cloud instance and how to do it...
Benefit Risk
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Marion Lepmets

CEO
March 17, 2023

The Benefit-Risk analysis (a.k.a. Benefit-Risk determination or Benefit-Risk ratio) is one of the most misinterpreted areas of the Risk Management process, in particular when coupled with the requirements of MDR / IVDR. And consequently one of the preferred digging points for the Notified Bodies. The spirit of the regulations and...