Rachel Callender

Recent Posts

WuXi AppTec Welcomes Sherry Parker, Ph.D., as Senior Director of Regulatory Toxicology

Posted by Rachel Callender on May 27, 2019
Today’s regulatory environment requires top-notch partners to help navigate preclinical testing. With that in mind, WuXi AppTec is very excited to announce the return of Dr. Sherry Parker! Dr. Parker has over 20 years of toxicology and medical device experience, and is an expert in analytical, pharmacological, and toxicological evaluations of medical devices and combination products. After pursuing another opportunity, her decision to return to WuXi only strengthens the strategic partnership that WuXi AppTec offers medical device manufacturers in need of preclinical safety testing.
 
Sherry Parker, Ph.D.
 
Most recently Dr. Parker was appointed to a three-year term as co-chair of the Advancing Safety in Health Technology / Biological Evaluation (AAMI/BE) Committee. In addition, she is an internationally recognized ISO expert, a U.S. Delegate for TC 194, the technical committee for ISO 10993-17. She is also the President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology (SOT).

From 2011 – 2018, Dr. Parker developed the Risk Assessment program here at WuXi AppTec. She has always been committed to the program and its success. In Mike McGrew’s own words, Vice President of Medical Device Operations at WuXi AppTec, “We are thoroughly excited to have Dr. Parker back at WuXi AppTec, her commitment and participation within the global regulatory industry only enhances the expertise we bring to our customers.”

While at WuXi, Dr. Parker will provide our customers with guidance on global regulatory and technical requirements and designing test plans. Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology, and also an international and U.S. delegate for TC 194 says, “We are thrilled to have Dr. Parker back on the team, the knowledge and experience she brings is priceless.”

WuXi AppTec commits to collaborating with the medical device industry to push boundaries and innovate for the good of patients and caregivers globally.  Our focus is to be an extension of your team, whether it is MDR or staying apprised of ISO 10993 updates.

Questions about MDR, global regulation updates or your medical device’s preclinical testing strategy? Contact us now to discuss your questions.

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Topics: Regulatory, validation, Reprocessing, MDR, Class Ir, Reusable Device

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