There is a point in almost every medical-device startup when the quality management system stops being something the team can tolerate and becomes something the company must actively control. In the beginning, paper can work. Shared drives can work. A few spreadsheets can work. Everyone…
A connected QMS platform that grows with your company Medical-device companies do not all need the same QMS on day one. Some teams are still moving from paper forms, Word templates and spreadsheet logs into controlled records. Others are managing CAPA, change control, risk, training,…
This AI Act Medical Devices Expert Perspective examines why many industry professionals believe medical AI was already heavily regulated before the EU AI Act. This article is part of our EU AI Act Learning Guide, where you can find all four articles in this series.…
What this is about: Most teams think the hard part of the EU AI Act is writing the documents. It is not. The hard part is keeping everything connected and current every time your AI changes. This explains why, in plain English, and what to…
AI Act High-Risk Medical Devices are one of the most misunderstood parts of the EU AI Act. If you build AI into a medical device, this guide explains how to determine whether your product falls into that category. Part 2 of 3 in our plain-English…
For AI Act August 2 Medical Device Companies questions, the most important thing to understand is which requirements apply now and which have been delayed. What this is about: You keep seeing “the EU AI Act” and “August 2nd” in the news. This explains, in plain…
qmsWrapper 10.2 is now live, introducing advanced QMS change impact analysis alongside major improvements across AI, Change Management, Forms, Processes, and Technical File control. At the center of this release is Wrapper-Mapper: an AI engine that analyzes change impact across your Technical File and the…
Change control in medical devices often begins later than it should.By the time the change control process starts, the original signal may have appeared weeks earlier. A change request is opened.The impact is evaluated.The Technical File is updated. On paper, the process looks correct. But…
Why semantic AI Search is the missing glue between quality, design, and risk There’s one audit moment QMS Managers dread—not because they did something wrong, but because proving it is exhausting. The auditor asks: “Show me how this issue connects to risk, design, and verification…
How MedTech teams move from static DHF storage to a living Design Traceability File (DTF) Every QMS Manager recognizes this moment: A design change happens—small on paper, huge in consequences. And suddenly the same questions return: This is where traceability often fails.Not because teams don’t…
