EPINTEK

EPINTEK
kiko.zhao@epintek.com (+86) 18217311271
苏州
215000 Suzhou
China
epintek.com

Our company

熠品集团是一家具有政府投资背景的医疗器械技术服务平台,公司聚焦于快速发展的医疗器械、生物医药行业,为国内外制造企业与科研院所提供:临床前研究、检验检测、法规注册与临床试验CRO等集成式一体化服务。熠品运营中心位于上海市虹桥商务区,生物医疗实验室位于苏州市吴江区,电气医疗和无线通讯实验室位于苏州市工业园区,耗材检测中心、手术室与大动物中心、华南生物医疗研发与检测中心位于贵阳市白云区,骨科与植介入器械研发检测中心位于合肥市高新区。

Yipin Group is a medical device technology service platform with government investment background. The company focuses on the rapidly developing medical device and biopharmaceutical industries, providing integrated services such as preclinical research, inspection and testing, regulatory registration, and clinical trial CRO for domestic and foreign manufacturing enterprises and research institutes. The Yipin Operation Center is located in Hongqiao Business District, Shanghai. The Biomedical Laboratory is located in Wujiang District, Suzhou. The Electrical Medical and Wireless Communication Laboratory is located in the Industrial Park of Suzhou. The Consumable Testing Center, Operating Room and Large Animal Center, South China Biomedical R&D and Testing Center are located in Baiyun District, Guiyang. The Orthopedic and Implant Interventional Device R&D and Testing Center is located in the High tech Zone of Hefei.

Our products and solutions

熠品实验室是目前国内为数不多的重资产合同研发外包实验室,先后获得了中国CNAS,CMA资质,以及美国A2LA,IAS等资质,生物实验室可执行FDA GLP体系。为客户提供医疗器械电气安全检测、性能试验、EMC电磁兼容、动物试验、化学表征、微生物试验、生物相容性、清洗消毒灭菌验证、包装老化、物理化学性能等综合性检测服务。也能够提供医疗器械风险分析、有限元分析、软件评估、可用性工程、临床评价等综合性技术服务,可满足企业从研发到临床注册过程的各种研发与检测需求。

Yipin Laboratory is currently one of the few heavy asset contract research and development outsourcing laboratories in China. It has obtained qualifications such as CNAS and CMA in China, as well as A2LA and IAS in the United States. The biological laboratory can implement the FDA GLP system. Provide customers with comprehensive testing services such as Electrical safety testing, performance testing, EMC electromagnetic compatibility, animal testing, chemical characterization, microbial testing, biocompatibility, cleaning, disinfection and sterilization verification, packaging aging, and physical and chemical properties of medical devices. It can also provide comprehensive technical services such as medical device risk analysis, finite element analysis, software evaluation, usability engineering, and clinical evaluation, which can meet various R&D and testing needs of enterprises from R&D to clinical registration.

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