WuXi AppTec Now Offers Dual Route Subchronic Toxicity Test

For your medical device study designs and protocols, our scientists build in the most effective in-vivo or in-vitro model to meet the study goals and stay compliant with governing laws, including...

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WuXi AppTec Attends FDA Workshop “Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards"

Our technical and regulatory experts actively participated in the workshop and its biocompatibility round table discussion.

The Federal Drug Administration (FDA) continues to focus on an approach...

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A Risk-Based Approach to Medical Device Testing Starts with Extractables and Leachables

As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.

And just as materials...

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WuXi AppTec Names Mark Cunningham as Senior Director of Science and Technology

WuXi AppTec is pleased to announce that Mark Cunningham, Ph.D., has accepted the position of Senior Director of Science and Technology.

Dr. Cunningham brings more than 25 years of experience in...

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WuXi AppTec Offers PTT Testing with BFT II Analysis

Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has...

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WuXi AppTec Joins Industry Leaders on Extractables & Leachables at E&L USA

WuXi AppTec returns to E&L USA this May in Bethesda, MD.

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The Changing Landscape Of Medtech Regulation

PLEASE JOIN US ON THURSDAY MAY 3RD FROM 3:00 PM TO 4:30 PM FOR “THE CHANGING LANDSCAPE OF MEDTECH REGULATION,”

UNIVERSITY ENTERPRISE LABORATORIES (UEL) WITH SPEAKER DR. VANESSA HAASE, ASSOCIATE...

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