ISO 10993-18 Updates: What You Need to Know

The International Organization for Standardization (ISO) released long-anticipated changes to standard 10993-18 on January 15, 2020. Updates will impact chemical characterization and toxicological...

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WuXi AppTec Welcomes Sherry Parker, Ph.D., as Senior Director of Regulatory Toxicology

Today’s regulatory environment requires top-notch partners to help navigate preclinical testing. With that in mind, WuXi AppTec is very excited to announce the return of Dr. Sherry Parker! Dr....
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Preparing for MDR: Don’t Forget about Class I Reusable Devices

Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough...

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MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO...

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ISO 10993-1: The Importance of Chemical Characterization

Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again! Our Director of Analytical Chemistry, and International Delegate for ISO 10993 part 18, Sandi...

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A Regulatory Consultant's Guide to ISO 10993 Updates Webinar

With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing...

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WuXi AppTec to Exhibit at DeviceTalks West, Costa Mesa, California

Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the...

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wuxi apptec to exhibit at devicetalks boston

Visit the WuXi AppTec exhibitor booth #513 at DeviceTalks Boston, which takes place Oct. 8-10, 2018. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that...

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Register Now for the PDA Chapter Dinner and Biocompatibility Presentation

WuXi AppTec Associate Director of Regulatory Toxicology Vanessa Haase, PhD, will present on biocompatibility testing as part of biological evaluation and ISO 10993.

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Helping Manufacturers Understand Product Bioburden Before Dose Setting

To determine the best-suited dose-setting method, we first help manufacturers better understand product bioburden by employing the most effective testing methods and techniques.

We are equipped to...

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