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Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
Picture this: You have just finished writing your requirements specification and saved it as “Requirements_final.doc” Then come the edits, code reviews, and compliance feedback. Suddenly you’re looking at three files: “Requirements_final_v2.doc”, “Requirements_final_really_final.doc”, and “Requirements_fixed_final.doc”. Which one’s actually the final one? You send one to the team, but they build from...
Marion Lepmets
During Atlassian Team25 Europe, the Compliance Alliance hosted the 4th Compliance Workshop in Barcelona. Despite a wild thunderstorm, nearly 30 compliance enthusiasts braved the rain to join the workshop – a session packed with insights on AI in regulated industries, Atlassian Isolated Cloud, Cybersecurity of Marketplace Cloud apps, and selling...
