Blog

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

Picture of Marion Lepmets

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

Subscribe to the SoftComply Blog

Stay connected with SoftComply and receive new blog posts in your inbox.

Empowered team
Picture of Marion Lepmets

Marion Lepmets

CEO
October 19, 2023

The exact quote from our customer that inspired this heading was: “There’s a delicate balance between holding team members accountable and coming across like a jerk.” This speaks volumes of the additional complexity that comes with Risk Management. You would think that the complexity lies within putting the correct method,...

Document Manager Oct23
Picture of Marion Lepmets

Marion Lepmets

CEO
October 19, 2023

SoftComply Document Manager is the newest Confluence Cloud app for managing documents with dedicated Workflows and e-Signatures. With this app you will turn your Confluence Cloud into a compliant document management system with: Book a Dedicated Live Demo call to check out the full functionality of the SoftComply Document Manager!...

Document Manager
Picture of Marion Lepmets

Marion Lepmets

CEO
September 11, 2023

TL;DR INTRODUCTION Choosing the appropriate document management system for your company is a critical task. You will commit the company and employees to a specific software tools for years to come. The choice of the correct platform depends on many factors, such as user requirements, size of the company and...

Automation Assistant of the Risk Manager Plus
Picture of Marion Lepmets

Marion Lepmets

CEO
August 24, 2023

We have just released a new Automation Assistant for the SoftComply Risk Manager Plus app – a feature some of you have requested. We heard you and we have now delivered it 😉 With the Automation Assistant you can automatically set values to your risks without having to set them...

InfoSec
Picture of Marion Lepmets

Marion Lepmets

CEO
July 26, 2023

What is Information Security Risk Management? Information security risk management is a systematic process that involves identifying, assessing, prioritizing, and mitigating potential risks that could compromise an organization’s information assets. These assets may include customer data, intellectual property, financial information, or proprietary business processes. The risk management process allows companies...

Monitoring Changes of Confluence Cloud
Picture of Marion Lepmets

Marion Lepmets

CEO
June 28, 2023

Confluence Cloud is constantly changing and not all the changes that are implemented by Atlassian are gated, i.e. they can’t be verified over the 2 weeks of Atlassian Release Tracks. SoftComply Validation app for Confluence Cloud is developed to monitor changes in and ensure the data integrity of your Confluence...