摘 要 　　　医疗器械作为一种特殊的产品，其安全性和有效性与人们的健康乃至生命都息息相关，医疗器械的风险还包括对社会财产和环境的损坏等。作为医疗器械制造商，无论从对病人、对使用者和其他相关人员负责的角度还是从满足监管要求的角度，全面和有效地开展医疗器械风险管理活动，都是必要的工作。 　　　本文基于制造商视角，研究如何依托制造商内部按YY/T 0287-2003标准建立、实施的质量管理体系，贯彻YY/T 0316-2008标准，将风险管理的各项要求有机地融合在质量管理体系当中，建立一套完整覆盖产品生命周期全过程的风险管理体系。本文首先对国内外研究现状进行了综述；对YY/T 0316-2008标准条款进行了解析，厘清了风险管理活动的流程和方法，并对几种常用的风险分析工具进行了比较，确定了其适用范围；从制造商的角度对不同类别的医疗器械产品如何开展风险分析、风险评价、风险控制等活动进行了剖析，试图寻找其内在规律，探讨具有可操作性的风险分析工具，对风险分析、评价和风险控制过程中的关键点和需要注意的问题进行了讨论和总结。最后，通过“聚乳酸防粘连膜”产品的风险管理实证研究，验证所研究的风险分析工具的可操作性及其风险控制措施的有效性。本文的研究将有利于医疗器械制造商风险管理体系的构建或完善。

ABSTRACT 　　　Medical Devices as a special product, its safety and effectiveness with people's health and life are closely related to people's health and life. The risk of medical devices also include social and environmental property damage. As a manufacturer of medical devices, both from the patient, user and other persons responsible for the point of view or from the perspective of meeting regulatory requirements, comprehensive and effective implementation of the medical device risk management activities, all necessary work. 　　　Based on the manufacturer perspective on how manufacturers rely on internal press YY / T 0287-2003 standard for establishing, implementing the quality management system, implement YY/T0316-2008 standards, requirements for risk management in the organic integration of quality management system among establish a complete product lifecycle covering the whole process of risk management system. Firstly, the current research were reviewed ; against YY/T 0316-2008 standard terms of the resolution, to clarify the procedures and methods of risk management activities, and several common risk analysis tools were compared to determine their scope; from the manufacturer's perspective on how different categories of medical devices to carry out a risk analysis, risk assessment and risk control activities were analyzed, trying to find its inherent laws, investigate risk analysis tool workable on risk analysis evaluation and risk control process of the key points and issues that need attention are discussed and summarized. Finally, the effectiveness through the" polylactic acid anti-adhesion film ," An Empirical Study of risk management products, risk analysis studies to verify the operability of tools and risk control measures. This study will help to build or improve the medical device manufacturer 's risk management system.