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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-device-development-risk-management-course/
课程评论：没有评论
课程名称: ISO 14971 医疗器械开发与风险管理 概述: 本课程全面深入地讲解了根据ISO 14971:2019标准在医疗器械设计和开发过程中的风险管理应用。学员将学习如何避免在新医疗器械产品开发中常见的重大失误，掌握大量实践案例，使其能够在最短时间内轻松开发安全和有效的医疗器械。我们还提供了一套医疗器械文档模板包，让学员在提交监管申请时轻松应对。 此课程适合医疗器械行业的在职专业人士，包括电子工程师、机械工程师、系统工程师、固件开发人员、软件开发人员、数据科学家、质量保证专家、监管事务专业人士、项目经理以及其他参与医疗器械开发和合规的人士。该课程与国际标准ISO 14971:2019完全对齐，学员将学习如何将标准中规定的每个风险管理过程阶段应用于医疗器械设计和开发中。 建议在5天内完成课程，每天大约花费4小时。成功完成后，学员将掌握医疗器械开发及风险管理的应用知识，能够覆盖整个医疗器械生命周期。今天就开始您的旅程，成为医疗器械开发与风险管理的专家吧。
This comprehensive course provides an in-depth education on the application of risk management per ISO 14971:2019 during the design and development of medical devices.You will learn to avoid the major mistakes people make that stifle new medical device product developments. Access countless practical examples providing you with the knowledge to easily develop safe and effective medical devices in the fastest possible time. Peek behind the curtain at our medical device templates documentation pack designed to make your regulatory submissions a walk in the park.This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.The course is fully aligned with ISO 14971:2019, the international standard for the application of risk management to medical devices. You will learn how to apply each phase of the risk management process outlined in the standard to medical device design and development.It is recommended to complete the course over 5 days, taking about 4 hours a day to complete, and upon successful completion, participants will be proficient in medical device development & the application of medical device risk management over the entire medical-device lifecycle.Start your journey today to become a medical device development & risk management expert.
