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...
WuXi AppTec Offers PTT Testing with BFT II Analysis
Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility
Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has...
Wuxi AppTec Provides Wide Range of Consulting Services
Depend on the Industry Expertise and Broad Knowledge Base of WuXi AppTec’s Consulting Services
WuXi AppTec Names former FDA Commissioner’s fellow as a Senior Scientific Director
Regulatory, FDA, Scientific Director, consultant
We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.