Software Tool Validation in the Medical Device Industry – A White Paper
Marion Lepmets
CEO
March 6, 2023
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Marion Lepmets
CEO
October 24, 2025
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
CEO
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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
CEO
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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...
