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

👉 If you’re involved in RA/QA, R&D, toxicology, or clinical development, this conversation gives you a practical roadmap for navigating the transition to the new ISO 10993-1.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

Marina Daineko Linkedin: https://www.linkedin.com/in/marinadaineko/

Intrinsic Medical Group, LLC: https://www.linkedin.com/company/intrinsic-medical-group/posts/?feedView=all

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice