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Biocompatibility Testing: Is It Always Necessary to Repeat It?
Feb 24, 2025
ISEMED Channel: our space dedicated to manufacturers of medical devices, IVDs, cosmetics, and biocides.
Here you'll find updates, innovations, and regulatory insights to stay up to date in a constantly evolving sector.
In this new video, we’ll explore whether it’s always necessary to repeat all biocompatibility tests. In fact, a proper gap analysis can help avoid repeating certain tests, optimizing both time and resources.
Lorenzo Pasotti, Regulatory Affairs Consultant at ISEMED, helps us understand how to assess the compliance of existing data and effectively address the requirements of Notified Bodies.
Learn more about how to make biocompatibility validation more efficient!
Watch the video 👇