Risk Management Of R&D Project Of Automatic Fluorescence Immunoassay Equipment In Dingshi Company

With the development of China's socialist market economy in a more and more in-depth direction,China's medical device production field has greatly improved compared with the past in terms of industrial scale and technical level.This aspect has made China's medical device product market more and more rich in product categories,the product's technical level and functional quality have been greatly improved,and it has also made investment in medical device production R & D more and more,and the technical requirements The higher,this has caused some risks in product development for medical device manufacturers in the actual production process,because research and development in this area requires a large investment,a long cycle and high safety requirements.The risk of R & D is higher than that of general industrial products or consumer goods.How to reduce the risk of medical device product development and improve the success rate of medical device product development is an important issue that every medical device manufacturing company must think deeply about and face.This article is based on the full life cycle theory of the research and development project,taking the research and development of Dingshi's automatic fluorescent immunoassay equipment as an example,using the Delphi method,scenario analysis method,brainstorming method,etc.to develop the automatic fluorescent immunoassay equipment The relevant background,the significance of risk research,the theory involved,and the current domestic and foreign related researches are analyzed in depth.Based on this,this article analyzes from the four stages of project establishment,design development,design transfer and mass production maintenance From the perspective of risk theory,according to the risk plan of the company where the automatic fluorescent immunoassay equipment is located,the risk encountered by the equipment during the research and development process and the management measures the company has made to avoid the risk are analyzed.Finally,according to the order of risk identification,risk assessment and risk monitoring,the risks in thestages of project establishment,design,verification,etc.of the automatic fluorescent immunoassay equipment were studied in sequence,and the analytic hierarchy process and expert scoring method were used to evaluate each risk.The size of the risk factors and the total level of risk,the conclusion is that there are planned risks,organizational risks,technical risks,control risks,etc.in the process of risk research and development,and the distribution of risk points in each risk is based on This puts forward the countermeasures to avoid the risk of automatic fluorescent immunoassay equipment,including the risk control list strategy,the strategy of grading risk control,and the strategy of monitoring the remaining risks.This paper combines theory with practice,and through the research in this paper,improves the risk management level of Dingshi's research and development projects to ensure that the project can be successfully completed.The research results of this article provide a strong basis for the future risk management of Dingshi's new product research and development projects,and provide a reference case for the future risk management of medical device product research and development projects.