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FDA fully recognized IEC 61326-2-6:2025 and included it in ASCA on July 28, 2025. Here’s what changes and how IVD manufacturers should respond.
read on for the bottom line and 4 key takeaways…
On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.
We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.
Once the 4th Edition is published, redesigns and QMS updates will be far more costly.
Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.