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Testing and Inspection Center

The testing center, a subsidiary of Trauson (China) Medical Instrument Co., Ltd, is composed of 5 sections: Quality Control Office, Physical Testing Office, Chemical Testing Office, Microbial Testing Office and the Integrated Office. The center mainly carries out testing programs from each branches of Trauson, including testing of raw materials, process control, performance testing of finished products and failure analysis of products and materials by physical or chemical testing and instrumental analysis. The center is supported by well-equipped testing laboratory and a professional team composed of technologists with bachelor degree or above and half of them are masters. The team’s professional background and working experience are all helpful to the conduct of mechanical testing, metallographic examination, chemical testing, microbial testing and material failure analysis.

Currently, the testing center has an overall area of more than 1000m2 and has an investment of more than 25 million RMB in fixed assets. It’s equipped with 50 pieces of testing equipment of which 30 pieces are internationally advanced analysis instruments, mainly including dynamic fatigue testing machine, tension-torsion testing machine for composite material, universal hardness tester, SEM, ICP-AES, gas chromatograph and electrochemical measuring device etc.

Our center established quality management system in full compliance with ISO17025 in 2011. After 3-year continuous improvement of quality system and testing ability, we submitted the laboratory accreditation application to CNAS in March, 2013 and passed the on-site audit in October, 2013. The CNAS officially announced Trauson’s testing center is certified by ISO17025 in December 2013. Meanwhile, our testing center initially acknowledged the testing range involves trauma, spine, joint related products and metallography, hardness and mechanical properties of raw materials. 20 testing methods are adopted like ASTM F1717, ASTMF2077, ASTM F382, ASTM F543, ISO 7206-4, ISO 7206-6 and ISO 14879-1 etc.

In addition, the center is also responsible for drafting and verifying the related medical device test standards for SFDA. So far, we have completed drafting and verification of 6 standards on product’s coating performance, mechanical properties of polyethylene and etc.

The testing center owns perfect quality system, scientific management and professional testing skills. All members of the center work together, keep innovation and ensure the accuracy of testing results, contributing to exquisite testing service and development of medical device technology.

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Structure

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