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…
Why MedTech teams need “Events” before CAPA, and why a Quality Event System (QES) is not a task list In the old world, it works like this: An engineer emails you: “I noticed something off during testing.”You reply: “Thanks—please track it.”A task gets created.The conversation…
Maybe it’s doesn’t make a big difference, but it does actually! Based also on many requests of our clients, here it is. qmsWrapper File App The Wrapper File App was developed to make file/document editing easier and safer. It saves time and makes your job…
QMSR key changes have been discussed in the medical device industry for years. Most QA/RA professionals are already familiar with the headline: FDA is aligning 21 CFR Part 820 with ISO 13485:2016. What is QMSR? The Quality Management System Regulation (QMSR) is FDA’s amended quality…
