ANSI/AAMI ST72:2019 provides guidance for BET/LAL of implantable medical devices.
ISO 11607 & MDR Impacts on Package Testing & Validation
Medical device manufacturers around the world are working to ensure their package designs are in line with the recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation...
ISO 10993-18 Updates: What You Need to Know
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...