General Info

WuXi AppTec Medical Device Team 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. WuXi AppTec’s 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 presubmission meeting support. In addition, we track regulatory trends through sponsor or regulatory inquiries we receive, and will adapt our strategy based on trends analyzed by our regulatory and technical experts. These trends, combined with our transparency with regulatory agencies, has aided in our approach to reprocessing cleaning and disinfection efficacy and validation studies. Above all, we stand behind our work – from test plans through clearance – responding to questions or other regulatory requests as part of the submission process.