x公司医疗器械产品研发阶段的风险管理研究uxqdllzg.doc

X公司医疗器械产品研发阶段的风险管理研究 北京理工大学工商管理硕士(MBA)学位论文 摘要 医疗器械行业已经成为目前增长昀快的行业之一。然而,由于医疗器械产品应用 范围的特殊性使得医疗器械产品的设计、生产、使用以及售后的监督控制过程与其它 产品相比具有更多的复杂性和不确定性,又因其与人类生命安全息息相关,因而具有 了更高的风险性。如何对医疗器械实施有效的风险管理,确保公众用械安全有效已经 成为医疗器械行业面临的巨大挑战。 本文从医疗器械的法规和标准要求入手,以国际标准 ISO14971 以及质量管理体 系其他有关技术和管理标准为昀基本依据, 针对目前 X公司医疗器械研发阶段面临的 主要问题,从研发的技术和过程管理两个方面出发,运用初步危害分析(PHA)和故 障树分析法(FTA)等工具,以高风险类医疗器械-胰岛素泵为例说明如何在医疗器械 产品研发阶段进行技术风险分析,并通过收集分析 X公司和其他设计中心研发过程中 存在的问题,对目前研发流程中潜在的管理风险进行识别、并依据制定的风险可接受 准则对其进行评价,并采取相应的风险控制措施以提高产品设计质量,优化设计流程, 昀大程度地减少对用户和患者的伤害,保障用户和患者的用械安全,使医疗器械的使 用风险与受益达到昀优化。 昀后,对本文课题进行了总结和展望。 关键词:风险管理 医疗器械 研发阶段 II 北京理工大学工商管理硕士(MBA)学位论文 Abstract Currently, the medical device industry is one of the fastest increase businesses, but because of its special application scope, there are more complex and uncertain situations than other products during the monitoring and control process of development, manufacturing, distribution and post-selling, and it has higher risk than others since it is closely related to human life. How to implement risk management effectively for medical device and ensure public safety under controll is a great challenge for medical device industryBase on ISO 14971 international standard, medical device quality management system and other related technical and management standards, this paper is focused on problems happening in X Company’s medical device development process, and takes some examples to help to explain how to identify, evaluate technical and process management risk in development phase of medical device, by means of risk analysis, evaluation and control methods and tools. It is also discussed in this paper on how to take effective risk control action to improve product design quality, optimize development process, reduce hazard possibility to user and patient, ensure safety for end user, and ultimately make optimal balance between risk and benefitIn the end of this paper, summary is drawn, and some key points are discussed which c