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

Preparing for MDR: Don’t Forget about Class I Reusable Devices

Posted by Britney Bartel, Marketing Manager on February 26, 2019

Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations - 

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

Poor Extraction Methods Can Impact Study Results

Posted by Dan Fowler, Principal Scientist on October 09, 2018

When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.

The purpose of an extraction process is to recover any residual soils from the medical device or testing substrate and then quantify those residuals for specific test markers such as protein, hemoglobin or carbohydrates.

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Topics: Medical Device, Technical Expertise, Reprocessing, Regulatory Expertise

Cleaning Validations and Process Robustness: How to Build a Study Design

Posted by Dan Fowler, Principal Scientist on August 14, 2018

The process of cleaning medical devices, either in healthcare settings or at a third-party manufacturer, includes many operational steps and variables. To prove the robustness of process design and to validate that normal process variables do not impact a product’s acceptance criteria, a cleaning validation is executed.

To comply with the 2015 FDA Guidance on reprocessing of medical devices, the validation design for your product should prove the following:

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Topics: Medical Device, Technical Expertise, Microbiology, Reprocessing, Regulatory Expertise

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

Posted by Dan Fowler, Principal Scientist on July 03, 2018

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 medical device’s life cycle, it may be used from one to many hundreds of times. For a reusable or third-party reprocessed product, it may be contaminated, cleaned and disinfected/sterilized multiple times throughout its clinical use.

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Topics: Medical Device, Regulatory, Technical Expertise, Reprocessing, Validation Study