SGS 致力于为医疗器械和生物/制药行业提供专业的检验和实验室服务,是国际公认的测试、检验和认证机构以及GMP/GLP 合规服务实验室。SGS生命科学实验室已为医疗器械及制药行业提供数十年高质量的分析测试服务。实验室多次通过 NMPA、FDA 现场核查,并拥有多种产品成功申报中国、美国、欧盟的经验。
SGS is committed to providing professional testing and laboratory services to the medical device and bio/pharmaceutical industries. SGS is an internationally recognized testing, inspection, and certification organization, as well as a GMP/GLP compliance services laboratories. SGS Pharma laboratories have been providing high quality analytical testing services to the medical device and pharmaceutical industries for decades. The laboratory has passed NMPA and FDA on-site audit many times, and also has experience in the successful declaration of many products in China, the United States and the European Union.
SGS医疗器械实验室相继获得了CANS、CMA、CBTL、NRTL、NVLAP、GAC、A2LA、ASCA等实验室认可资质,其中上海无源实验室同时依照GMP/GLP运行,不仅为医疗器械产品提供全面的微生物、理化、生物学评价及电气安全等测试服务,还提供有效的质量解决方案以满足客户的定制化需求,如:骨科产品清洁验证、可重复使用医疗器械清洗验证、材料化学表征与含药器械的相容性研究、包装验证、洁净室验证等。为医疗器产品的研发、注册与生产提供支持,帮助医疗器械及医药企业保证产品合规,为产品快速上市、企业的快速发展提供基石。
SGS Medical Device laboratories have been accredited by CANS, CMA, CBTL, NRTL, NVLAP, GAC, A2LA, ASCA, etc. The Shanghai Non-active Medical Device Laboratory operates with GMP/GLP compliance. We do not only provide comprehensive Microbiological Test, Physicochemical Test and Biocompatibility Evaluation of medical device and electrical safety testing services, but also offer effective quality solutions to meet customized needs of our customers, such as: Cleaning Validation, Chemical Characterization, Biocompatibility Evaluation, Packing Verification and Medical Device Testing& Certification Service, etc. We support the R&D, registration and production of medical device products, and also help medical device and pharmaceutical companies to ensure product compliance, providing the cornerstone for rapid product launch and enterprise development.