Research Of A Medical Device Company Quality Management System Improvement

Since the Chinese Medical Device Quality Management Regulations (trial version) has been implemented on January1,2011and Regulation on the Supervision and Management of Medical Device (revised draft) was effective on June1,2014, all the aspects of the supervision and management of medical devices have been covered, including reregistration, innovation review, production and distribution. Medical device GMP has entered a stage of full implementation, the medical device industry especially for the small and medium size manufacturing enterprises are facing to the pressure and driving force of the development of integration.A medical device company is a private small and medium production enterprise, facing to the higher and more comprehensive requirements of quality management system, considering the existing problems of the implementation, A medical device company should strategic thinking the questions of quality system improvement to prevent the quality problems and make products more competitive, to propelling the company developed rapidly.Based on the currently existing quality problems and the analysis of root causes, combining with the theory of total quality management, new regulations and actual situations of A medical device company, this article addressed a detailed improvement plan and concrete measures from four aspects of quality management system documents, design and development, design transfer and supplier quality management through PDCA cycles. The results of this article has practical value to ensure the product quality of medical device manufacturing, and has provide a reference to quality management system improvement for other domestic small and medium medical device enterprises.