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PUBLISHED ARTICLE

The New and Improved ISO 10993-12:2021—What Is Really Changing?

Published In: MDDI Online

Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a gap between what is expected from the regulation and what was done when the testing or assessment for a medical device was originally performed. This time, however, I must say that the updated document was only slightly modified, without unexpected twists and turns, so everyone can breathe a little easier.

 

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Helin Räägel, PhD

Helin Räägel, PhD

Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...