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药明康德医疗器械测试中心，拥有丰富的医疗器械测试经验的一体化医疗器械服务平台，提供包括：生物相容性测试、化学测试、毒理学风险评估、微生物检测和大动物研究在内的测试服务。测试服务流程均遵从且满足全球监管法规准则，具备FDA GLP、OECD GLP、CNAS/A2LA、ISO17025、CMA和FDA ASCA资质，拥有AAALAC认证的动物设施，现代化的手术室和实验室及中国和美国双认证的动物外科专家、兽医病理学家和毒理学家。可以出具同时满足中国、美国和OECD成员国注册申报的测试报告，实现“一份报告，全球申报”。
WuXi AppTec Medical Device Testing Center, is an integrated medical device service platform with extensive experience in medical device testing. We provide services including biocompatibility testing, chemical testing, toxicology risk assessment, microbiological testing, large animal studies and pathology research. Our testing services comply with global regulatory guidelines, holding FDA GLP, OECD GLP, CNAS/A2LA, ISO17025, CMA, and FDA ASCA accreditations. We have AAALAC-certifiedanimal facilities,state-of-the-art operating rooms and laboratories, as well as dual-certified animal surgeons, veterinary pathologists, and toxicologists in both China and the United States. We can issue testing reports that fulfill the registration requirements of China, the United States, and OECD member countries, achieving“one report, global submission”.
八大核心业务：
大动物实验
化学测试
毒理学风险评估
生物相容性
生物学评价
微生物测试
病理学平台
注册及临床
Eight core businesses:
Large animal research
Chemistry testing
Toxicological risk assessment
Biocompatibility
Biological evaluation
Microbiology
Pathology services
Registration.
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