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What is changing with the new ISO 10993-1 version 2025
The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.
Will we need to retest everything?
Is this a complete game-changer, or just an evolution?
How will Notified Bodies and the FDA react?
In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what’s really coming.
This episode covers:
The background and current status of the ISO 10993-1 revision
Why the new version is best seen as an evolution, not a revolution
How the standard pushes…
The skinny
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