About Us
EPINTEK GROUP is a medical device technical service platform with government investment. We focus on the rapidly developing medical device and biomedical industries to provide domestic and foreign manufacturing companies and research institutes with integrated services such as preclinical study, inspection and testing, regulatory affairs & registration and clinical trial CRO services.
The EPINTEK Operation Center is located in Hongqiao Central Business District, Shanghai; the biomedical laboratory is located in Wujiang District, Suzhou; the electrical medical & wireless communication (EMC) laboratory is located in Suzhou Industrial Park; the consumables testing center, operating rooms and large animal center, and the South China Biomedical R&D and Testing Center are located in Baiyun District, Guiyang; the R&D and Testing Center for Orthopedic, Implantable and Interventional Devices is located in Hefei High-tech Zone.
The EPINTEK GROUP is currently one of the few CROs for heavy assets in China. The EPINTEK laboratories have obtained CNAS, CMA, A2LA, IAS and other qualifications. We can provide rigorous and scientific CRO services and test reports for the Chinese, American and European markets.
These laboratories provide customers with comprehensive testing services for medical devices such as electrical safety testing, performance testing, electromagnetic compatibility, animal testing, chemical characterization, microbiological testing, biocompatibility, validation of cleaning, disinfection and sterilization, packaging aging, and physical and chemical properties. They can also provide comprehensive technical services for medical devices such as risk analysis, finite element analysis, software evaluation, usability engineering, and clinical evaluation, so as to meet various R&D and testing needs of enterprises from R&D to clinical registration.
EPINTEK has an experienced regulatory registration team. The core team members are mainly from medical device research, development and manufacturing enterprises and international regulatory consulting service providers, and they are familiar with medical device registration, regulations for accreditation, quality systems and testing requirements in the Chinese, American and European markets.
The clinical trial team of EPINTEK, consisting of divisions of medical editing, clinical monitoring, data collation, statistical analysis, and quality control, has the ability to provide full-process services for clinical trials from project initiation, protocol design, site screening, quality control to reporting, and provide clinical data assurance for registration.
