The International Organization for Standardization (ISO) released long-anticipated changes to standard 10993-18 on January 15, 2020. Updates will impact chemical characterization and toxicological...
Stop Letting GLP Stunt Your Chemistry Studies
The FDA’s Good Laboratory Practice (GLP) regulations have led to some misconceptions for medical device manufacturers (MDMs). To better understand the misconceptions about when to apply GLP...
WuXi Medical Device Testing Doubles Chemistry Capacity
As industry analysts predicted, laboratory testing facilities are experiencing capacity constraints due to Europe’s Medical Device Regulation (MDR). To accommodate the high demand and help...
Are you MDR ready? Let WuXi AppTec be your guide at BIOMEDevice in San Jose
Medical device manufacturers are busy preparing for MDR, while standards continue to be revised. The environment is constantly evolving – let WuXi Medical Device Testing be your guide. We provide...
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....
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...
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...
ISO 10993-1: The Importance of Chemical Characterization
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...
A Regulatory Consultant's Guide to ISO 10993 Updates Webinar
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...
Our All-Inclusive Approach to Microbial Identification
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...