Our Team



Graduated from Shanghai Jiaotong University School of Medicine, major in biomedical engineering and medical instrument. With 20 years management experience in large-scale medical equipment manufacturing enterprise, in the medical device registration, quality management system, the project management has a wealth of experience.

This was independent and responsible for the three types of sterile medical equipment project. According to GMP requirements for sterile medical devices, from the plant site selection, design, construction production process layout, product testing, clinical trials to the system through examination, well built covers an area of 45 acres, the building area of 35000 square meters plant.

Have an intimate knowledge of the Chinese medical equipment registration regulations, which include the active, passive, implantation, sterile medical devices, have completed 34 medical instrument registration.

▲adept at preparing the European CE certification required TCF document, has coached and help 12 enterprises to obtain the CE certification.

▲can independently accomplish the United States FDA510k report, familiar with QSR820 system of the United States, helped the 3 Chinese enterprises through the United States FDA check the factory.

With 10 years of foreign medical equipment manufacturing enterprises R & D and production experience. Be familiar with the three category of medical devices registration, register, change procedures, including writing the product standard, type test, clinical validation, writing technical report of product, product risk analysis report.

* in the three category of medical equipment research and development work for many years, from the early planning, trial, test pilot to successfully turn received registration approval, mass production of listed. Successfully registered the three types of sterile medical equipment 11.

A good medical equipment GMP system, including GMP, GMP, sterile implant in vitro diagnostic reagents. Help enterprises through 3 medical equipment GMP system assessment.

In the key process, special process validation has a wealth of practical experience, such as sterile process validation, verification, validation, sealing water system equipment of DQ, OQ, PQ etc..

Know the medical equipment technical standards, in the microbiology experiment, cell toxicity test, chemical analysis experience.