医疗器械研发项目风险管理研究

发布时间：2018-01-05 05:11

本文关键词：医疗器械研发项目风险管理研究　出处：《中国科学院大学（工程管理与信息技术学院）》2014年硕士论文　论文类型：学位论文

【摘要】：医疗器械研发项目具有跨学科、难度大、周期长、法规要求严格等特点,由此也决定了它的高风险特征。如何有效地规避医疗器械研发的高风险是我国医疗器械研发工作者的迫切要求和艰巨任务。因此,分析医疗器械研发活动中存在的风险因素,进行有效的风险管理,对于我国医疗器械产业可持续发展有着十分重要的理论意义和现实意义。本文将在理论研究的基础上,结合医疗器械研发项目实例,运用项目风险管理的知识和方法,从项目角度出发对医疗器械研发项目的风险管理进行探索。作者完成的主要工作包含以下几个方面的内容： (1)简单介绍了本文的研究背景和意义,在参阅相关文献资料的基础上,综合描述了医疗器械风险管理的现状和进展。 (2)对医疗器械研发企业的组织机构和项目开发过程进行了详细的梳理,协调组织由相关领域专家组成风险管理小组采用访谈、头脑风暴等方法对可能出现的风险因素进行了识别,识别出医疗器械研发项目可能出现的5类16种风险因素形成风险因素清单,采取问卷调查的形式对形成的风险因素清单进行实证研究,确保其准确性和客观性。 (3)采用层次分析法构造判断矩阵对各风险因素进行了重要度排序,形成研发各阶段主要风险清单,根据不同风险类型按照减轻、规避、分担和接受的策略制定了合理的风险应对措施,并对风险的应对情况进行监控。 (4)以高强度聚焦超声治疗系统研发项目风险管理作为研究案例,按照以上的理论方法对其实施风险管理,分析其中的风险并加以控制,达到对理论研究的可行性和可操作性加以验证的目的。本文是对医疗器械研发过程从项目角度应用风险管理知识和方法的一次探索性研究,其研究成果对医疗器械研发工作有一定的指导和参考价值,同时也有助于项目风险管理理论的进一步深化。
[Abstract]:Medical device R & D project has the characteristics of interdisciplinary, difficult, long cycle, strict regulations and so on. This also determines its high risk characteristics. How to effectively avoid the high risk of medical device research and development is the urgent requirement and arduous task of medical device R & D workers in China. It is of great theoretical and practical significance for the sustainable development of medical device industry to analyze the risk factors existing in the research and development of medical devices and carry out effective risk management. On the basis of theoretical research, this paper will use the knowledge and methods of project risk management in combination with the example of medical device R & D project. This paper explores the risk management of the medical device R & D project from the perspective of the project. The main work accomplished by the author includes the following aspects: This paper briefly introduces the research background and significance of this paper and describes the current situation and progress of medical device risk management on the basis of referring to relevant literature. The organization organization and project development process of the medical device R & D enterprise are combed in detail, and the coordination organization is composed of experts in the related field to form the risk management group to adopt the interview. Brainstorming and other methods identified the possible risk factors, and identified 5 types of 16 risk factors that may appear in the R & D project of medical devices to form a list of risk factors. The form of questionnaire survey is used to make an empirical study on the list of risk factors to ensure its accuracy and objectivity. (3) Analytic hierarchy process (AHP) is used to construct judgment matrix to rank the importance of each risk factor, and to form the main risk list in each stage of R & D, according to different risk types according to mitigation and avoidance. The strategy of sharing and accepting makes reasonable measures to deal with risk, and monitors the situation of risk response. Taking the research and development project risk management of high-intensity focused ultrasound therapy system as a case study, according to the above theoretical methods to implement risk management, analyze the risk and control it. The feasibility and maneuverability of the theoretical research are verified. This paper is an exploratory study on the application of risk management knowledge and methods in the process of medical device R & D from the perspective of the project. The research results have certain guidance and reference value for the R & D of medical device. At the same time, it also helps to deepen the theory of project risk management.
【学位授予单位】：中国科学院大学（工程管理与信息技术学院）
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F426.4

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