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Author: Helin Räägel





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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March 1, 2023

The Bumpy Road to MDR

“The [European Union’s] MDR aims to provide a higher level of protection for patients, but the transition has been anything but smooth. Manufacturers are struggling to keep up with the extra checks, and the EU notified bodies are overwhelmed,” writes...

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June 7, 2022

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on...

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April 7, 2022

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...

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