EPIN Tech

EPINTEK is a technical, integrated CRO service & consulting platform [LL1] focusing on medical device and biomedical material testing. EPINTEK provides international medical device and biomedical material manufacturing enterprises and research institutes with services covering preclinical research, inspection and testing, regulatory registration and clinical trials.

 

EPINTEK’s highly experienced and professional regulatory team members are mainly from medical device manufacturing and R&D enterprises, as well as international regulatory consulting agencies. We are familiar with medical device registration (NMPA, FDA, CE), certification regulations, quality systems and testing requirements, along with our clinical trial staff with expertise in medical writing, clinical monitoring, data collation, statistical analysis, quality control and so on.

 

Meanwhile, EPINTEK has built up a comprehensive service network in China, including operation center (Shanghai), biomedical laboratory (Suzhou), electrical medical and wireless communication laboratory (Suzhou), medical consumables testing laboratory and the large animal laboratory (Guiyang), and testing center for orthopedics, dental and implant interventional device (Hefei).

 

For all these labs/testing centers mentioned, EPINTEK has all been recognized/accredited by ILAC CNAS international accreditation qualification, China's national CMA qualification, and American A2LA, IAS and other international accreditation qualifications. EPINTEK’s biological laboratory can implement the FDA GLP system, thus enabling us to provide rigorous and scientific R&D outsourcing services and testing reports for the Chinese, American and European markets.

 

Enabled by these sophisticated and mature laboratory facilities, EPINTEK can meet the various R&D and testing needs of enterprises from R&D to clinical registration, providing clients with comprehensive services and one-stop solutions, such as:

• electrical safety testing

• performance testing

• EMC electromagnetic compatibility and RF testing

• animal testing

• chemical characterization

• microbial testing

• biocompatibility

• repeatability of medical devices

• comprehensive testing services for medical devices in process verification

• packaging aging

• physical and chemical properties testing

• medical device risk analysis

• software evaluation

• usability engineering

• clinical evaluation