This study，conduct statistical analysis on the number of medical device enterprise certification and the number of enterprise personnel that have passed the ISO 13485：2016 quality management system certification，based on the comprehensive supervision platform of certification and accreditation business. It is found that 80% of the second and third class medical device manufacturers that have passed the quality certification in China are small and micro enterprises with less than 100 persons. By analyzing the current situation of small and micro medical device enterprises in China，this paper points out the bottleneck hindering the quality management of small and micro medical device enterprises，and with the help of the “small and micro enterprise quality management system certification promotion action” promoted by the General Administration of market supervision and administration，puts forward the ways to help the quality development of small and micro medical device enterprises. The development of small and micro medical device enterprises should not only rely on the reform of “release，management and service” of the regulatory department，but also continuously improve the quality to enhance the survival ability and anti risk ability of small and micro enterprises. The main ways include：（1）establish medical device compliance system；（2）make clear the market orientation of products and actively benchmarking with international standards；（3）continuously improve personnel ability and quality awareness；（4）use process method and pay attention to the risk points in the process.