About Us
Honor
The company has established a complete quality system in accordance with ISO13485, "Medical Device Manufacturing Quality Management Regulations" and EU regulations. The company has passed the ISO13485 quality system certification of TUV South Germany and the EU CE product certification.
The company has passed the on-site inspection of the product certification of the domestic drug regulatory system, and has obtained 7 domestic product registration certificates, namely, single-use rotary live sampling forceps, single-use live sampling forceps, and single-use cervical live sampling forceps. One-time use of foreign body forceps, one-time use of cell brushes, one-time use of endoscopic injection tubes, and one-time use of bile duct drainage tubes.
Quality control
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 And other high-precision testing equipment, the testing center is equipped with a number of full-time inspectors with rich experience and complete inspection technology to conduct inspections.
The company uses strict management methods, resource provision, product realization, measurement analysis and improvement related process activities, carries out 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 hospitals and the second class hospitals across the country, and its stable product quality has been recognized by customers.
Honor
The company has established a complete quality system in accordance with ISO13485, "Medical Device Manufacturing Quality Management Regulations" and EU regulations. The company has passed the ISO13485 quality system certification of TUV South Germany and the EU CE product certification.
The company has passed the on-site inspection of the product certification of the domestic drug regulatory system, and has obtained 7 domestic product registration certificates, namely, single-use rotary live sampling forceps, single-use live sampling forceps, and single-use cervical live sampling forceps. One-time use of foreign body forceps, one-time use of cell brushes, one-time use of endoscopic injection tubes, and one-time use of bile duct drainage tubes.
Quality control
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 And other high-precision testing equipment, the testing center is equipped with a number of full-time inspectors with rich experience and complete inspection technology to conduct inspections.
The company uses strict management methods, resource provision, product realization, measurement analysis and improvement related process activities, carries out 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 hospitals and the second class hospitals across the country, and its stable product quality has been recognized by customers.