What company produces the medical device safety assessment report?

If it is for medical device registration, it should be "Medical Device Risk Analysis". The report is prepared by the company itself, the existence of medical devices to analyze the risk, the existence of risk to warn, protect, prompt instructions to reduce the risk is acceptable. The main basis of the "People's Republic of China *** and the State Pharmaceutical Industry Standard: Medical Devices Risk Management for Medical Devices (YY/T 0316-2008/ISO 14971:2007)" by the State Food and Drug Administration, Department of Medical Devices. People's Republic of China*** and the State Pharmaceutical Industry Standard: Medical Devices Application of Risk Management to Medical Devices (YY/T 0316-2008/ISO 14971:2007) is under the purview of the Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices (SAC/TC 221). People's Republic of China *** and the State Pharmaceutical Industry Standard: Medical Devices Risk Management for Medical Devices (YY/T 0316-2008/ISO 14971:2007) Drafting unit: Medical Devices Quality Management and General Requirements Standardization Technical Committee, Beijing State Medical Device Huaguang Certification Co. Can be analyzed against the standard article by article.