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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Biocompatibility as a Critical Design Input

Published Date: February 27, 2024

For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be cleared for the market. This evaluation is usually the last step in device development and is performed per ISO 10993-1. While biocompatibility should be assessed using the final version of the device, it should not be an afterthought; rather, biocompatibility should be an important consideration during the design process. This webinar provides an overview of biocompatibility and the various aspects of a biological evaluation.

Learn more about the presenter 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...

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