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Author: Thor Rollins





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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May 25, 2023

The MDR Delay’s Impact on Regulatory and Testing

“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must...

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September 17, 2022

Burden of Proof: An Orthopedic Testing & Analysis Roundtable

With the rise of orthopedic device evaluation and updating of standards, testing laboratories must be at the forefront of analytical knowledge to partner with orthopedic device makers. In this article, Thor Rollins from Nelson labs and other industry experts share...

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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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