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  • WKU R&D Center, 2413 Nashville Rd., Bowling Green, KY
  • +1 270-792-5768
  • +1 270-282-2096

Fully following the requirements of EN ISO13485:2012 from the beginning of establishment, Innosurg Medical Device Technology Co.,Ltd of Ningbo obtained the DNV GL Certification in April 2016, then the CE Certification for Trocar(developed by Innosurg). Other products developed by Innosurg such as Laparoscopic surgery equipment s(Endoscopic Retriever, Flusher, Aerated Filter,etc.), Defaecation Device, Skin anastomat and Drainage tube/bag will constantly join the CE Certification list.  Innosurg complies fully with the requirements of relevant national legislation and policies and ensure that all the products meet with the international standards and medical industry standards.

Innosurg always focuses on the quality of products, and the Quality control team is leaded by seniors involved in medical industry quality management for more than 10 years. Quality control department is equipped with biochemistry and physics laboratories to do validation and testing for microorganism, sterility and physical performances of products and components. The environment of  clean workshops and laboratories, workers dressing and personal hygiene, the state of equipment are monitored and controlled periodically in accordance with the regulations. IQC、IPQC、FQC、OQC 、QE、QA are set to ensure the parts are inspected and controlled by QC during different stages of the process. Once purchased parts enter factory, they will be inspected in accordance with IQC and AQL. During the productive process, manufacturing procedure, semi-finish products and related activities are inspected periodically in accordance with IPQC, to ensure the process meets with the requirements of SOP and SIP. According to the Internal Control Procedure, once there’re problems, they will be handled effectively in time by QE and R&D using QC methods and PDCA procedure. The appearance/performance of finished products will be 100% inspected by FQC, and the products will be checked by OQC before shipment. All quality activities are kept in record to form quality reports.


The professional team to service !