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biocompatibility

June 20, 2018

The Risk-Based “Big Three”

Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too...

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September 15, 2017

Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and,...

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September 13, 2016

Martell Winters Shares Expertise with University Students

Martell Winters, consultant and senior scientist at Nelson Laboratories, is now instructing a course at Brigham Young University (BYU) entitled “Industrial Microbiology and Sterilization.” The course is limited to juniors, seniors, and graduate students and is focused on providing a...

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July 6, 2016

New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes

As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...

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May 17, 2016

Celebrating Audrey Turley: 20 Years at Nelson Laboratories

Since Audrey Turley started her career 20 years ago at Nelson Laboratories, she has worked in various departments including bioburden, biocompatibility, and technical consulting. She has cross-trained in other sections and has performed IDs, air sampling in hospitals, hydrostatic pressure,...

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