Blog

Achieving CE Mark Faster: Amiko’s Story of Agile Compliance with a Confluence-Based Document Management System

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Marion Lepmets

CEO
December 3, 2025

We recently sat down with Elisa Lo Blanco, Quality Assurance and Regulatory Affairs Manager at Amiko, a digital health company focused on chronic respiratory conditions, to discuss their journey to achieving CE marking under the Medical Device Regulation (MDR). Amiko’s success highlights how MedTech startups can balance the need for…

Digital QMS on Confluence Cloud

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Risk Automotive
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Marion Lepmets

CEO
June 26, 2023

Why Jira for your Risk Register? Risk Management is an essential governance practice for enterprise, product, portfolio, information security and project management. For many of us, the Risk Register is still stuck in a MS Excel spreadsheet that someone like the Project Coordinator or the Risk Manager tries to keep...

RAID
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Marion Lepmets

CEO
May 24, 2023

Ensuring Data Integrity of your Confluence Cloud instance with the SoftComply Validation app when Migrating from Confluence Server to Cloud – Automated Testing of Atlassian Confluence Migrating from Confluence Server to Confluence Cloud can be a complex process, especially when it comes to ensuring data integrity and maintaining validation status....

Object Register
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Marion Lepmets

CEO
May 24, 2023

Introduction The SoftComply Risk Manager Plus is the most advanced risk management app in Jira. It supports a wide range of features including the ability to: SoftComply Risk Manager Plus is easy to use and can be integrated with Jira, making it a valuable tool for organizations of all sizes....

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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...