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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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Hazard analysis and FMEA
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Marion Lepmets

CEO
March 21, 2024
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples....
SoftComply Risk Manager Plus
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Marion Lepmets

CEO
March 11, 2024

Risk management in the regulated industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It’s a common misconception that risk management slows down innovation and adds unnecessary layers of bureaucracy. Yet, in reality, effective risk management is the linchpin of...

information security risk management in jira
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Marion Lepmets

CEO
March 6, 2024

Being an ISO 27001-compliant company means that you protect your information assets and client data against possible data breaches. It supports your business growth as it builds trust in your company and your products. In the hopes of achieving ISO 27001 compliance quickly, many companies purchase a huge ISO 27001...

Image: Warner Bros.
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Marion Lepmets

CEO
February 27, 2024

“It’s a dangerous business, Frodo, going out your door. You step onto the road, and if you don’t keep your feet, there’s no knowing where you might be swept off to.” (B. Baggins) The same applies in business in general – no company operates without risks. For you to have...

What risk
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Marion Lepmets

CEO
February 19, 2024

More often than not, Risk Managers confess to us that when they ask their colleagues about the critical risks in their department, the answer is: “We have no risks!” This is a problem, since it highlights that the concept – what is a risk – is unclear. We recommend Risk...

Dilbert Document Management
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Marion Lepmets

CEO
February 14, 2024

INTRODUCTION Although paper records still have their place in the modern industry, most companies use one or more software applications to manage documentation. Choosing the appropriate electronic document management system (eDMS) for your company is a critical task. You will commit the company and employees to a specific software tools...