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Published Articles



Our experts are featured in industry-leading publications and provide deep insights into the science behind our services.



November 20, 2018

Understanding the Importance of TIR17 for Medical Device Manufacturers

Published In: Medical Plastics News

Understanding the importance of TIR17 for medical device manufacturers: TIR17 has evolved over the years to be a necessary resource...

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October 22, 2018

Consider the Most Probable Number Method for Bioburden Testing

Published In: MD+DI

The MPN method can be useful when traditional bioburden tests won’t work, but it must be clearly understood and carefully...

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October 1, 2018

Understanding Worst-case Conditions in ISO 18562 Testing

Published In: Medical Design & Outsourcing

For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The...

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September 1, 2018

Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

Published In: Medical Design Briefs

When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in...

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July 23, 2018

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

Published In: Medical Device Outsourcing

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

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