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Home > Medical Device made Easy Podcast > What is changing with the new ISO 10993-1 version 2025 
Podcast: Medical Device made Easy Podcast
Episode:

What is changing with the new ISO 10993-1 version 2025 
Category: Business
Duration: 00:00:00
Publish Date: 2025-11-27 00:00:00
Description:
miniature episode 364 What is changing with the new ISO 10993-1 version 2025 Easy medical device monir el azzouzi

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 further into a risk-based, scientifically justified approach
  • The link with ISO 14971 and lifecycle thinking
  • Changes in contact categorization and cumulative exposure
  • The industry trend toward reducing animal testing through in vitro methods and data-driven justification
  • How to conduct a gap analysis once the new standard is published
  • Practical advice on how to prioritize updates without freezing projects or panicking
  • Real-world examples where process chemicals, not base materials, changed the risk picture
  • How Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices

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