苏州苏大卫生与环境技术研究所有限公司(简称“苏大检测”)源于苏州医学院,作为具有独立企业法人资格的第三方技术服务机构,公司致力于解决医疗器械产品研发过程中的材料、产品设计以及临床前评价与测试等关键环节和难题。同时以成为行业和地方标杆的产学研一体化基地为旨,充分利用苏州大学在人才、技术和设备方面的优质资源,发展成为全国医疗器械出口检测的龙头企业。
Sanitation & Environment Technology Institute of Soochow University Ltd, (hereinafter referred to as "SUDA Testing") originated from Suzhou Medical College, as a third-party technical service institution with independent enterprise legal entity. The company is committed to solving key links and problems such as materials, product design, preclinical evaluation and testing in the process of medical device product development. At the same time, with the aim of becoming an industry-university-research integration base of industry and local benchmarks, Soochow University fully takes advantage of its high-quality resources in talents, technology and equipment, it has developed into a leading enterprise in the field of national medical device export testing.
是最早获得国家CMA&CNAS 认定认可的第三方医疗器械检测机构;
是国内唯一通过美国FDA医疗器械类GLP符合性监管审核的检测机构(截至2022年);
是国内最早开展医疗器械欧盟CE认证检测的第三方机构;
紧密依靠苏州大学骨科研究所,行业经验厚积40载,帮助中国智造走向世界;
拥有国内一流的临床医生、毒理学家、病理学家、动物学家、技术研发团队。
It is the first third-party medical device testing organization to obtain the recognition of national CMA & CNAS;
It is the only testing organization in China that has passed the US FDA GLP compliance regulatory audit for medical devices (as of 2022);
It is the earliest third-party organization in China to carry out EU CE certification testing of medical devices;
Closely relying on the Institute of Orthopedics of Soochow University, with 40 years of industry experience, we have helped China's intelligent manufacturing to the world;
It has a domestic first-class clinician, toxicologist, pathologist, zoologist and technical research and development team.