关键词: 体外诊断医疗器械, 研发项目, 全生命周期, 风险管理

Abstract:

 In recent years， with the development of society and the improvement of national economic strength， China's in vitro diagnostic medical device industry is booming.The market size is huge， but at the same time， the industry pain points are increasingly significant. The R&D project of in vitro diagnostic medical devices has the characteristics of interdisciplinary， high investment and heavy tasks， and there are many uncertainties in the research and development process， which also make risk management crucial to the success of the entire project. Therefore， this study takes risk management as the starting point， combined with in vitro diagnostic medical device R&D project examples， to explore the whole process of establishing a whole life cycle risk management mechanism， in order to provide a theoretical basis and guiding significance for enterprises to carry out in vitro diagnostic medical device risk management. Through the identification， analysis and judgment of risks at different stages of the whole life cycle of the R&D project， and the adoption of corresponding control measures and verification means，to make the risk of the product within the acceptable range， ensure the successful implementation of the project and bring benefits to the enterprise.

Key words:  , In vitro diagnostic medical devices； , R&, D project； , Whole life cycle； , Risk management