Quality Management In Medical Device Research And Development Projects

Since the end of the 20 th century,China's medical device industry develops very quickly.When the people pursue to improve their material life constantly,they also gradually pay attention to health and medical treatment,especially the quality of medical device.As we all know,medical device is a high-risk,high-technology product.It must have excellent quality due to its professional and particular background.Therefore,the quality management must be strictly controlled at the different stages of medical device research and development projects,as far as possible to reduce the risk of products.Strengthening quality management and complying with international standards of quality management system,is the important trends of internationalization of domestic medical device industry.It is also the inevitable choice of strengthen products and expand the market.Strive to improve the quality management in medical device research and development,not only help enterprises to establish and perfect a set of a high standard of quality management standards,but also help enterprises to improve competitiveness in the industry even in the international market.This thesis is guided by the project management and quality management theory,it analyzes the research and development project's present situation and the existing problems of CS medical device company,and then it uses six sigma DMAIC improvement methods to continuously improve the existing project development process.In the process of implementation,the thesis firstly defines the problems of the existing problems in detail,and secondly it measures the relevant measurement data and keeps statistics,then it determines the problems as well as the root cause of the problems in the research and development projects process by analyzing.Finally,it proposes the corresponding process improvement measures base on the results of the analysis.The measures are increasing the document review,adding the unit test code inspection in the development phase,increasing the smoke test,etc.After improving the process,it enhances the cooperative relationship between project members,and makes to improve the research and development efficiency significantly.The thesis applies the improved new processes to the specific project case.The data results show that the new process not only reduces the defect rate,shortens the development time,and also saves the development costs,improves customer satisfaction and brings more economic benefits to the enterprise.Finally,the thesis summarizes the introduction of six sigma management method in medical device research and development projects,states the main achievements and puts forward the prospect to do further research in this field in the future.