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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Important to Address the Stacked Effects of Soil Accumulation on Medical Devices

After each use of a medical device, soil may accumulate at a microscopic or macroscopic level that could potentially impede the terminal disinfection or sterilization process.

Over the course of a...

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WuXi AppTec Names Tim Drain as Director of Sales

WuXi AppTec is pleased to announce that Tim Drain has accepted the position of Director of Sales for the Laboratory Testing Division Medical Device Platform.

Tim has had an impressive career...

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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 Provides Wide Range of Consulting Services

Depend on the Industry Expertise and Broad Knowledge Base of WuXi AppTec’s Consulting Services

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WuXi AppTec Names former FDA Commissioner’s fellow as a Senior Scientific Director

We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.

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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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