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

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

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.

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?

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

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

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 –

• Device classification changes
• New classes of medical devices, including Class Ir for reusable devices.
• Lack of extensions for Class Ir
• Grandfathering in legacy devices will be strictly prohibited.

As of May 26, 2020, every Class Ir device must have an MDR CE mark to be permitted in the market.

Learn more about the new subclass for Class Ir under MDR and the necessary steps to ensure compliance in the recent MedTech Intelligence article by Dan Fowler, WuXi AppTec’s Principal Scientist for reprocessing.

“Preparing for MDR: Don’t Forget about Class I Reusable Devices” echoes countless experts on the importance of timelines and preparation. It also highlights critical components of robust validation studies for reusable devices, five rules of testing to keep in mind, reasons studies fail, and more.

Read the Full Article