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

Posted by Rachel Callender on February 19, 2019

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 10993-18 as part of TC 194 / Working Group 14.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

ISO 10993-1: The Importance of Chemical Characterization

Posted by Rachel Callender on January 16, 2019

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 Schaible explains why chemical characterization should be the driver behind your biocompatibility testing plan.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

A Regulatory Consultant's Guide to ISO 10993 Updates Webinar

Posted by Rachel Callender on January 15, 2019

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 alone to obtain regulatory approval.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

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

Posted by Britney Bartel, Marketing Manager on April 25, 2018

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

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, Biological Safety Testing, E & L