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所在平台: Udemy |
课程主页: https://www.udemy.com/course/practical-regulatory-affairs-2020-european-medical-devices/
课程评论：没有评论
**实用法规事务2020 - 欧洲医疗器械** **课程概述:** 欧盟医疗器械法规（MDR 2017/745）是过去二十多年来欧洲医疗器械立法最重大的变革。MDR 影响所有希望在欧盟销售器械的医疗器械制造商（及其他相关方）。本课程侧重于 MDR 的实际应用，通过真实世界的案例和练习，帮助您不仅理解法规的含义，更重要的是理解我们需要做什么来合规。本课程由一群目前在行业内工作的法规事务专业人士撰写和开发，重点关注医疗器械制造商在过渡到 MDR 时最常见的问题和疑问。
The EU Medical Device Regulations (MDR 2017/745) represents the biggest change to medical device legislation in Europe for over 20 years. The MDR affects all medical device manufacturers (and others!) wanting to sell devices in the EU. This course focuses on the practical application of the MDR, using real-world examples and exercises to help you understand not only what the Regulations mean, but what we need to do to comply with them.Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to transition to the MDR.
