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所在平台: Udemy |
课程主页: https://www.udemy.com/course/applied-iso-14971-medical-device-risk-management/
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**课程名称：** 应用ISO14971医疗器械风险管理 **课程概述：** 该课程基于ISO 14971:2007标准，时长2.4小时。旨在为阅读80页的标准提供简洁而全面的医疗器械风险管理知识，并帮助初入医疗器械行业的新人快速入门。课程重点讲解失效模式与影响分析（FMEA）和故障树分析（FTA）等关键工具的使用，以便于立即应用于ISO 14971项目。课程提供系统化的方法来理解医疗器械风险管理，并连接风险管理方法论的重要要素，促进原则的有效应用。此外，课程还指导如何进行有效的会议，以构建医疗器械风险档案。 **课程重要性：** 执行风险管理是法律法规的要求，也是评估医疗器械安全性的基础工具。风险管理是产品设计和开发过程中的设计输入要求之一，意味着风险控制和危害降低措施必须作为关键考虑因素纳入医疗器械的最终设计以及验证和确认研究中。风险评估应贯穿生产和生产后过程的整个周期。 **课程亮点：** * **有条理且系统化的方法：** 帮助理解并应用ISO 14971原则。 * **商业视角：** 采用商业方法进行医疗器械风险管理，推荐项目管理技术来建立风险管理团队结构，确保组织范围内的支持和承诺，以符合ISO 14971的要求。 * **详尽的工具讲解：** 深入讨论FMEA和FTA，清晰解释其在医疗器械风险管理中的适用性。 **提供的课程材料和资源：** * 7个实践工作坊 * 风险管理计划模板 * 定量风险/效益分析技术报告 * MS Excel格式的FMEA工作表 * AAMI白皮书：《风险原则与医疗器械》
The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. This 2.4-hour long course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects. This course offers a systematic methodology to comprehend medical device risk management and connects the vital elements of risk management methodologies for a more efficient application of principles. It also provides guidelines on how to conduct productive meetings to construct medical device risk profiles. Why is this course essential to take? Performing risk management is a regulatory obligation and is the underpinning tool for assessing medical device safety. Risk management is part of the design input requirements during product design & development. This means that risk control and hazard reduction measures must be included as key considerations in the final medical device design, as well as in verification and validation studies. Risk evaluation should occur continuously throughout the production and post-production processes. An organised and methodical approach to understanding and applying the ISO14971 principles This ISO 14971 course takes a business approach to medical device risk management. Business tools such as project management techniques are recommended to establish risk management team structures. This ensures an organisation-wide support and commitment to comply with the ISO 14971 requirements. The Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis are discussed in greater detail to clearly explain their applicability to medical device risk management. Course materials and resources provided 7 practice workshopsRisk management plan templateQuantitative risk/benefit analysis technical reportFMEA worksheet in MS Excel formatAAMI White Paper: Risk Principles and Medical Devices
