Medical Device Platform Blog
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WuXi AppTec Welcomes Sherry Parker, Ph.D., as Senior Director of Regulatory Toxicology
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.
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ISO 10993-1: The Importance of Chemical Characterization
Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again!
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MDR & ISO 10993-1: How to Navigate Preclinical Device Testing
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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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.
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