Research on Evaluation of Quality Management System of Medical Device Enterprises
Quality management system is the foundation and guarantee for the legal and compliant operation and development of an enterprise,especially a medical device enterprise.It is a long-term attention to establish a quality management evaluating index system and evaluating model effectively and reasonably for many medical device enterprises,in order to finding the problems according to the evaluation results and propose the improvement project,then improve the quality management level continuously.Through the research and exploration on the evaluation of quality management systems in medical device enterprises,applying qualitative and quantitative systematic evaluation methods to the field of medical device quality management,enabling accurate and objective evaluations for all sections of quality management activities,providing some reference for the quality management of medical device enterprises.It is also beneficial to provide relevant research experience for the system evaluation in other similar fields.At the same time,This paper intends to construct an evaluation index system covering the whole life cycle of medical devices,in order to provide some reference for solving the problem that the research on quality management system evaluation is limited to a certain part of quality management,and the evaluation method is limited to the requirements of quality management system.