The WuXi Medical Device Testing team of experts supports manufacturers throughout the life cycle of their products, from concept phase to commercialization with unique expertise in preclinical safety testing. Our labs follow standards such as ISO, USP, ASTM, and AAMI to support global regulatory requirements. Our technical experts develop study designs specific to our customers’ device, its indication, and patient population that maintain scientific integrity and provide evidence of product safety. Our regulatory experts provide consultations on supporting test strategies, requests from regulatory agencies, design history file gap analysis, and pre-submission meeting support.
