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

Posted by Yvonne Leonard, Director of Marketing on June 05, 2018

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 characterization plays a role in device design and development, extractables and leachables studies play a role in regulatory submission and preclinical safety testing.

WuXi AppTec works with you to first determine the best analytical approach for your medical device. We help you determine testing parameters, based on the device’s classification and indication for use (such as the intended population, route of administration and clinical application).

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Topics: Medical Device, Leachables, Preclinical Safety, Extractables, Biological Safety Testing, Regulatory, consultant, Technical Expertise

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

Posted by Yvonne Leonard, Director of Marketing on May 29, 2018

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 the biopharmaceutical and contract research organization (CRO) industries supporting the R&D of pharmaceutical, biotech, medical device and combination products.

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Topics: Contract Research Organization, Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, Scientific Director, consultant, Technical Expertise

Wuxi AppTec Provides Wide Range of Consulting Services

Posted by Yvonne Leonard, Director of Marketing on May 15, 2018

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

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Topics: Regulatory, FDA, consultant

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

Posted by Yvonne Leonard, Director of Marketing on May 01, 2018

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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Topics: Regulatory, FDA, Scientific Director, consultant