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Author: Wendy Wangsgard





November 20, 2018

Understanding the Importance of TIR17 for Medical Device Manufacturers

Understanding the importance of TIR17 for medical device manufacturers: TIR17 has evolved over the years to be a necessary resource for device manufacturers, says Wendy Wangsgard, Nelson Labs. Read Full Story

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July 23, 2018

Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

What medical device manufacturers need to know about the recent changes to the ISO bioburden standard. Read Full Story

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March 10, 2017

Establishing Bioburden Alert and Action Levels

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom...

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