Research On Construction And Implementation Of Quality Management Evaluation System For Medical Device Enterprises

In this paper,do a study to the medical device quality management system evaluation based on domestic and foreign research progress,literature and QSR820 related theory and then select the Z company for case studies,including the following research:At first,by comparing the quality management system standards ISO13485 and QSR820,19 evaluation indexes were identified and classified into three categories according to the characteristics,and the medical device quality evaluation index system was constructed.Secondly,we use AHP to calculate the weights of the above 19 evaluation indexes for the quality system and to sort them comprehensively.The software also has real-time evaluation and query functions,to further improve the level of intelligent medical equipment enterprises,while reducing the error rate of manual calculation,improve work efficiency and timeliness.Finally,the project management theory is used to analyze the implementation process of the medical device quality management evaluation system.Finally,the establishment of the quality management evaluation system and evaluation software in the Z medical device company applied research.