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Published Article

PUBLISHED ARTICLE

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

Published In: Medical Device and Diagnostics Industry (MD+DI)

This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1.

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Learn more about the authors below.

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...

Thor Rollins

Thor Rollins

RM (NRCM)
Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...