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Author: Helin Räägel, PhD





December 4, 2024

All You Need to Know About Writing a Great BEP (Biological Evaluation Plan)

As with all projects, the planning phase is one of the more crucial elements to a successful outcome. In the same light, a biological evaluation plan (or BEP as we like to call it) is one of the core pieces...

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May 24, 2024

Aging with Grace: Key Discussion Points on End-of-Life Assessment

This whitepaper is a result of a discussion led by the authors as part of Veranex’s Biocompatibility Coffee Break in February 2024. It includes the critical industry questions that arose during the discussion. Download the PDF below. Learn about the...

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October 10, 2023

FDA Guidance 2023 on ISO 10993-1: What Changed?

This article by biocompatibility experts Helin Räägel, PhD, and Audrey Turley discusses the most recent FDA guidance on biological evaluations of medical devices per ISO 10993-1, highlighting the new guidance on intact skin contact. Read Full Article Learn more about...

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September 13, 2023

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1. Read Full Article Learn more about the authors below.

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June 26, 2023

PFAS: Medtech Restrictions and Impacts

Per- and polyfluoroalkyl substances, or PFAS, are chemicals that have been used in industry and consumer products for many years. A couple examples are medical device coatings and microwave popcorn bags. In this article published by Medical Device and Diagnostics...

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