Subject: Case Study: TIANYI MEDICAL Achieves FDA 510(k) Clearance
2025-11-04
WuXi AppTec Medical Device Testing Center is a specialized, integrated testing platform that brings extensive expertise and experience in the medical device field. We provide a broad spectrum of services that include biocompatibility testing, chemistry testing, toxicological risk assessment, microbiology testing, large animal studies, and pathology research.
Our center strictly adheres to global regulatory guidelines, as demonstrated by our accreditations from FDA GLP, FDA ASCA, OECD GLP, CNAS/A2LA ISO17025, and CMA. Our facilities are AAALAC-certified and equipped with state-of-the-art operating rooms and laboratories. Our team of professionals, including animal surgeons, veterinary pathologists, and toxicologists, hold dual certifications from both the US and China. This exceptional blend of expertise and accreditation enables us to deliver testing reports that meet global registration requirements, embodying our commitment to “One report, Global submission”.


Large animal experiment
Pathology Services
Chemical testing
Toxicological risk assessment
Microbiological test
Biocompatibility
Biological evaluation
Product registration
2025-11-04
Subject: Case Study: TIANYI MEDICAL Achieves FDA 510(k) Clearance
2025-09-01
Case Study | FDA Deficiency Response Delivered in 7 Days: How Our Toxicology Team Met the "Impossible" Deadline
2023-02-16
WuXi AppTec Named “Industry Mover” in S&P Global Sustainability Yearbook 2023
