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所在平台: Udemy |
课程主页: https://www.udemy.com/course/human-factors-and-usability-engineering-in-medical-devices/
课程评论：没有评论
课程名称：医疗器械的人因因素与可用性工程 课程概述： 医疗器械的可用性在患者安全、监管批准和市场成功中扮演着至关重要的角色。可用性差可能导致用户错误、设备误用及监管拒绝，增加患者和制造商的风险。本课程提供了一套全面的逐步指南，涵盖人因因素与可用性工程（HFE/UE），确保符合美国FDA、欧盟MDR、IEC 62366-1及ISO 14971的要求。您将学习如何将可用性工程原则应用于医疗器械设计，进行形成性和总结性可用性测试，以及将人因因素整合到风险管理中。课程内容包括监管期望、基于风险的可用性设计、用户界面（UI）设计最佳实践，以及监管提交所需的可用性文档。无论您是医疗器械工程师、监管专业人士、用户体验设计师还是临床医生，本课程都将为您提供优化设备可用性、减少用户错误并确保FDA、EU MDR合规所需的技能和工具。 课程学习内容： - 在医疗器械开发中应用人因工程（HFE）原则 - 在人工智能和软件医疗器械（SaMD）中应用人因工程（HFE）原则 - 确保遵循美国FDA、欧盟MDR、IEC 62366-1和ISO 14971的可用性要求 - 进行任务分析、可用性风险评估和可用性测试 - 设计直观、安全且用户友好的医疗器械 - 准备监管提交所需的人因因素文档 现在报名，提升您的医疗器械可用性专业知识！
Medical device usability plays a critical role in patient safety, regulatory approval, and market success. Poor usability can lead to user errors, device misuse, and regulatory rejections, increasing risks for both patients and manufacturers. This course provides a comprehensive, step-by-step guide to Human Factors and Usability Engineering (HFE/UE), ensuring compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971.You will learn how to apply usability engineering principles to medical device design, conduct formative and summative usability testing, and integrate Human Factors into risk management. The course covers regulatory expectations, risk-based usability design, user interface (UI) design best practices, and usability documentation for regulatory submissions.Whether you're a medical device engineer, regulatory professional, UX designer, or clinician, this course will equip you with the skills and tools to optimize device usability, reduce user errors, and ensure FDA, EU MDR compliance.What You Will Learn:Apply Human Factors Engineering (HFE) principles in medical device developmentApplying Human Factors Engineering (HFE) Principles in AI and Software as a Medical Device (SaMD)Ensure compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971 usability requirementsConduct task analysis, usability risk assessments, and usability testingDesign intuitive, safe, and user-friendly medical devicesPrepare Human Factors documentation for regulatory submissionsEnroll now and take your medical device usability expertise to the next level!
