Author: Lee Wence PhD

May 24, 2022

Lessons from the Lab eBook

This eBook addresses common challenges and best practices for medical-device manufacturers with questions about testing their products. Table of Contents: EO Optimization and Potential Effects on Sterile-Barrier Packaging Patient-Specific Implants Often Require More Testing Extractable Chemical Characterization and Risk Assessment:...

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October 14, 2021

Extractable Chemical Characterization and Risk Assessment: What is the Worst-Case?

While you may not want to think of the words “worst case” relating to your product, these words are critical in designing a chemical-characterization study and assessing those results in a toxicological-risk assessment. This blog post looks at general concepts...

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