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LIVE WEBINAR

Big Changes to ISO 10993-1: What Is Happening to the Main Biocompatibility Standard Now?

June 8, 2022

1:00 pm ET

Helin Räägel

In 2018 TC194, the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused more on a risk-based approach and made significant changes. Now more significant changes to the main biocompatibility standard are being made. In this webinar Helin Räägel will go over the areas of the standard that are being changed, the reasoning behind the changes, and the initial acceptance of these changes around the globe.

Helin Räägel

Helin Räägel

PhD
Senior 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...