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Posted: November 7, 2017

Sterigenics International LLC Changes Name to Sotera Health LLC

Leverages the strength of Nelson Labs, Nordion and Sterigenics to deliver on its mission of Safeguarding Global Health™

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Posted: March 7, 2018

A Brief Introduction to Medical Device Biocompatibility

By Matthew R. Jorgensen, PhD
Published: MD+DI

Biocompatibility of medical devices is a complex and evolving subject. Here's what you need to know.

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Posted: February 1, 2018

Accelerated Aging Package Testing

By: Pal Khangaldy & Wendy Mach The Packaging Department at Nelson Laboratories is often asked by manufacturers “What do I need to do to validate my packaging?” or “What package testing do I need to have performed in order to comply with regulations?” There is not a one-size-fits-all answer to these questions as unique product, packaging, […]

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Posted: February 7, 2018

Chemical Characterization: How to Prepare for the Future in This Time of Transition

Using chemical characterization to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will aide manufacturers in the selection of the application, including the recently published standard ISO 18562 that addresses gas path devices. This presentation will provide a brief overview of the goals of chemical characterization, current approaches, and anticipated changes based on our involvement in industry committees. Attendees will leave informed about how and why we do chemistry testing for medical devices.

Speaker: Matt Jorgensen, PhD

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