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Quality assurance



It is consistent quality policy of the company that “One Device Decides One Life, All Devices Embody Love, Sterility, Non-toxicity and nonpyrogenicity, Safety and Effectiveness of All Devices ensure health and peace”. With the sense of responsibility that “Quality is Life”and under the philosophy that “Quality Policy Is the Tenet of All Activities”, the company is devoted to designing and manufacturing safe and high-quality products for customers to fully meet or surpass expectation of customers and patients.

  • The company establishes and maintains an effective and rigorous medical device quality management system- ISO 13485.
  • The company possesses various advanced production equipments. All technological requirements can be fully satisfied.
  • The company has complete necessary technical apparatuses being properly installed and protected. All technological requirements can be satisfied in the aspects of quantity, variety and accuracy.
  • The company also has complete station facilities which are strictly and timely cleaned to ensure that no product is polluted in the circulation process.
  • The company conducts regular testing of class 100000 clean rooms to ensure that each index of clean room meets up to the requirements.
  • Monitoring and measuring equipments are complete in variety and being performed in good conditions. They can meet all requirements on testing of product’s performances.    
  • The company has established measuring management system. All metering instruments are periodically inspected or calibrated and used within the effective period
  • Inspectors, workers of special and key processes have been undergone professional training. They are on duty with certificates after passing examinations.
  • The company conducts inspection according to relative standards in each process (from the coming of raw materials to finish of products). Inspection records and reports of each batch products are all available to ensure the retroactivity of the products. 

 
Ningbo Tianyi Medical Devices Co., Ltd. 浙ICP备11064920号 POWERE BY   www.300.cn Add:No.788, mozhi north road, dongqian lake tourist resort, Ningbo Service Hotline:400-184-6998 gx1085@tianyinb.com