Software Tool Validation in the Medical Device Industry – A White Paper

March 6, 2023

WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION



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Digital QMS on Confluence Cloud
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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...

7 key considerations for AI tool developers
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Marion Lepmets

CEO
November 19, 2025

If you’re an Atlassian Marketplace app vendor or you’re exploring how to bring AI capabilities like Rovo into your products and services, this article is for you. AI is no longer optional – and neither is compliance. What used to be the domain of a few highly regulated sectors like...

InfoSec in Jira and Confluence
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Marion Lepmets

CEO
November 9, 2025

Is your organization struggling to keep up with crucial information security (InfoSec) management requirements? Today, every company faces a constant stream of threats, from ransomware and phishing to third-party vulnerabilities. In response, an increasing number of companies are standardizing their InfoSec efforts by following frameworks like ISO 27001 or SOC...