About Us

EPINTEK GROUP

A professional medical device technology platform providing end-to-end solutions for the global healthcare sector. We support manufacturers and research institutes across fast-growing medical device and biomedical markets with integrated services from R&D to regulatory clearance.

We serve the fast-growing medical device and biomedical sectors by providing global manufacturers and research institutes with end-to-end solutions, including:

       - Preclinical studies

       - Inspection & testing

       - Regulatory affairs & product registration

       - Clinical trial CRO services

       - CDMO services

Strategic Infrastructure

Our capital-intensive facilities include:

• Shanghai HQ: Hongqiao CBD Operations Center

• Suzhou Hub: Biomedical Lab (Wujiang District) + EMC Testing Lab (Industrial Park)

• Guiyang Center: Consumables Testing, OR Suites & Large Animal Facility (Baiyun District)

• Hefei Specialized: Orthopedic/Implantable Devices R&D Center (High-tech Zone)

Accredited Excellence

As one of China's few capital-intensive CROs, our CNAS/CMA/A2LA/IAS-accredited laboratories deliver globally compliant testing and validation for Chinese, US, and EU markets.

Comprehensive Testing Capabilities

• Core Testing: Electrical safety, EMC, biocompatibility, microbiological analysis

• Material Science: Chemical characterization, physicochemical properties

• Performance Validation: Package aging, sterilization efficacy, cleaning protocols

• Engineering Support: FEA, risk analysis, software validation, usability studies

Regulatory & Clinical Expertise

• Strategic Registration: Cross-market approval pathways (China NMPA/US FDA/EU MDR) led by former industry regulatory affairs executives

• Full-cycle Clinical Solutions:Protocol development, site management, medical writing, biometrics (data management + biostatistics), and audit-ready reporting