2016年国务院办公厅发布《关于促进医药产业健康发展的指导意见》,明确提出鼓励发展医疗设备第三方专业维护保养、售后服务队伍。2016年2月起实施的《医疗器械使用质量监督管理办法》要求各医院加强对医疗器械质量的监管。但是,在目前的医院管理模式下要实现医疗器械质量的全过程管理不太现实,一是人员数量不足;二 In 2016, the General Office of the State Council promulgated the Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry, and clearly proposed to encourage the development, maintenance and after-sales service team of third-party medical equipment. The Measures for the Administration of Quality Supervision and Administration of Medical Devices, which came into effect in February 2016, require hospitals to step up the regulation of the quality of medical devices. However, in the current hospital management model to achieve the whole process of medical device quality management is not realistic, first, the number of staff is insufficient; two