The company has established a complete quality system in accordance with ISO 13485, "Medical Device Manufacturing Quality Management Regulations" and EU regulations. The company has successively passed the on-site inspection of the domestic drug regulatory system and the ISO 13485 quality system and CE product certification of TUV South Germany.
The company has a product testing center and 10,000-level laboratories established in accordance with the requirements of the national GMP specifications, including particle analyzers, meteorological chromatographs, two-dimensional image measuring instruments, universal testing machines, 6% Luer taper joint multi-function testers, and needle points Sharpness detector, biochemical incubator, mold incubator, pressure steam sterilizer, aseptic operation table, constant temperature and humidity incubator, biological safety cabinet, hardness tester, analytical balance, spectrophotometer, PH meter, conductivity instrument such as high-precision testing equipment, the testing center is equipped with a number of full-time inspectors with rich experience and complete testing techniques to conduct testing.
The company uses strict management methods, resource provision, product realization, measurement analysis and improvement related process activities, real-time monitoring, and continuous improvement, so that every process and every link is meticulous, leaving no hidden dangers, and protecting medical equipment safe and effective. Since its establishment, the company has served the top three and second-tier hospitals across the country, and its stable product quality has been recognized by customers.