Skynor Medical Technology (Shanghai) Co., Ltd. announces the approval of the ISO 13485:2016 international system certification, and the obtainment of the international quality management system standard certification issued by TUV SUD group.

 

ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization published for the first time in 1996;it represents the requirements for a comprehensive quality management system for the designand manufacture of medical devices. 

 

This ISO 13485 certification covers the function of R&D, Manufacture and Sales of Neuro and Peripheral Interventional Product Lines.