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Published Articles



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



September 17, 2022

Burden of Proof: An Orthopedic Testing & Analysis Roundtable

Published In: Orthopedic Design and Technology (ODT)

With the rise of orthopedic device evaluation and updating of standards, testing laboratories must be at the forefront of analytical...

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June 24, 2022

A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?

Published In: American Pharmaceutical Review

In this article Steve Lynn from Regulatory Compliance Associates discuss why the top 10 FDA Form 483 issues have remained...

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June 7, 2022

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

Published In: Medical Device and Diagnostic Industry (MD+DI)

With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and...

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April 6, 2022

Initial Evaluation Roadmap for Modern Microbial Methods

Published In: Parenteral Drug Association (PDA)

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. It is the result...

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March 3, 2022

EO Optimization and Potential Effects on Sterile Barrier Packaging

Published In: Medical Product Outsourcing (MPO) Magazine

In this article Jennifer Gygi, Expert Technical Consultant at Nelson Labs, discusses how EO-optimization efforts can affect a manufacturer’s packaging...

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