涂层导尿管开发项目风险管理研究

发布时间：2018-02-24 06:28

本文关键词： 风险管理一次性医疗器械项目管理涂层导尿管　出处：《上海交通大学》2012年硕士论文　论文类型：学位论文

【摘要】：在现代医疗机构中，一次性医疗器械应用广泛，起着举足轻重的作用。医疗器械产品与病人的健康息息相关，所以风险管理对于一次性医疗器械特别重要，保证产品开发项目的成功。AS公司是一次性医疗器械生产厂家，正在开发涂层导尿管的项目，通过风险管理尽可能提高产品安全性，并保准企业实现利益最大化。本文首先从了解项目风险管理的理论知识现状开始，，然后对AS公司的涂层导尿管开发项目流程和要点进行分析，根据其流程就项目的产品概念，计划，设计和开发，验证和确认以及生产及上市五个阶段的风险管理进行研究，分析风险管理的任务。其中首先对风险进行策划，然后依据产品项目的要点具体识别了各方面的项目风险，并在其中提出了普通无菌导尿管风险检查表。其次采用故障树分析法结合半定量的方法对风险进行了量化和评估。最后根据分析的根本原因提出解决方案，利于本企业和同行业在开发此类产品时能够更有效的管理好项目，降低风险，满足最终用户需求。
[Abstract]:In modern medical institutions, disposable medical devices are widely used and play an important role. Medical device products are closely related to patients' health, so risk management is particularly important for disposable medical devices. To ensure the success of the product development project. As is a one-off medical device manufacturer, is developing a coated catheter project, through risk management to improve product safety as much as possible, and to protect the benefit of the enterprise to maximize. This paper begins with understanding the current situation of the theory of project risk management, and then analyzes the process and key points of the coating catheter development project of as Company, according to which the product concept, plan, design and development of the project are discussed. Research on risk management in five stages of validation and validation, production and marketing, and analysis of the task of risk management. Firstly, risk planning is carried out, and then the project risk is identified according to the key points of the product project. And put forward the risk check table of common aseptic catheter. Secondly, the method of fault tree analysis combined with semi-quantitative method is used to quantify and evaluate the risk. Finally, according to the root causes of the analysis, the solution is put forward. It is beneficial for the enterprise and the same industry to manage the project effectively, reduce the risk and meet the end user's demand when developing this kind of product.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R161

【参考文献】