The Risk Management Research In The Medical Device Laryngeal Mask Development Project Of Company A

In recent years,China medical device industry has achieved great progress,the proportion of the domestic economy is increasing,the industrial structure tends to rationalization.But compared with western developed countries medical device industry,China medical device industry still exists weak innovation ability lacking and low adding value problems.Research and development of medical devices take a long development cycle and strict requirements for safety are different from commercial consuming products.Improving the success rate of research and development is the essential need for survival and development of medical devices companies,the use of risk management is to ensure that the success of research and development project.The current risk management is still at initial stage for domestic medical device companies,failed to form as a more mature system.Therefore,the research and application of risk management for medical device research and development projects has a very important practical significance.This thesis will tak:e the laryngeal mask research and development project of Xiamen A company as the research case,apply the theory and method of risk management,and combine the project research and development process to carry out risk planning,identification,evaluation,control and monitoring.This thesis firstly discusses the status of new medical device research and development project’s risk management and analyzes the risk characteristics.Briefly introduce Xiamen A company and the Laryngeal mask project and then the key points and process of the laryngeal mask project are analyzed in detail.The risk planning of Laryngeal mask research and development project is introduced,including the establishment of risk management team,the establishment of project risk assessment model and the project risk assessment process.Risk identification of laryngeal mask project was carried out through Brainstorming method.According to the project research and development process,the risk was evaluated and controlled by Expert investigation and Failure mode and effective analysis method.To ensure the continuous and effective risk control for project risk,carry out the risk monitoring.Finally,the thesis summarizes the results and looks forward to the future work.