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 to Exhibit at DeviceTalks West, Costa Mesa, California

Posted by Rachel Callender on November 27, 2018

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 endpoints you need to support your products’ safety.

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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1, MDR

wuxi apptec to exhibit at devicetalks boston

Posted by Rachel Callender on October 04, 2018

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 will meet the endpoints you need to support your product’s safety.

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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1

Register Now for the PDA Chapter Dinner and Biocompatibility Presentation

Posted by Rachel Callender on September 17, 2018

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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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1

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