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.

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

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 - 

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

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.

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

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.

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

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.

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

WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.

Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have been introduced into the manufacturing process, is critical in determining the root cause of the microbial excursion, as well as effective corrective actions to prevent re-occurrence.  

Topics: Medical Device, Technical Expertise, Microbiology, Microbial Identification

Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data. 

Environmental monitoring is one way a device manufacturer demonstrates control within a production area. Environmental samples from water, air and surfaces support verification of process controls and ultimately support product safety. Trending this valuable data offers manufacturers a qualitative indicator of the cleanliness and controls within their production areas.

Topics: Medical Device, Technical Expertise, Microbiology

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

A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers. 

In last week’s blog post, we highlighted the importance of bioburden monitoring, both quantitatively and qualitatively, as supportive evidence for a valid radiation dose. We arrived at this conclusion through a historic data review of verification dose experiments.

Topics: Medical Device, Technical Expertise, ISO 11737-1, Radiation Sterilization Validation

WuXi AppTec supports the best practice of monitoring bioburden quantitatively and qualitatively to ensure the established radiation dose is valid.

For many medical device manufacturers, radiation sterilization is a critical element of sterility assurance programs. ISO 11137-1, ISO 11137-2 and ISO TS 13004 specify the requirements for establishing a sterilization dose based on known product bioburden, including quantity and resistance.

Topics: Medical Device, Technical Expertise, ISO 11737-1, Radiation Sterilization Validation