With many factors to consider, preparing a global submission may seem daunting, and adhering to the varying testing requirements and interpretations of standards of regional regulatory...
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...
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...
WuXi AppTec to Exhibit at DeviceTalks West, Costa Mesa, California
Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the...
Product Adoption for Sterilization Validation
When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?
There is another...
Poor Extraction Methods Can Impact Study Results
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...
wuxi apptec to exhibit at devicetalks boston
Visit the WuXi AppTec exhibitor booth #513 at DeviceTalks Boston, which takes place Oct. 8-10, 2018. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that...