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所在平台: Udemy |
课程主页: https://www.udemy.com/course/the-medical-device-regulation-for-medical-device-designers/
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课程名称：医疗器械法规（MDR）：为设备设计师的简介 概述：欢迎观看这系列短视频，介绍欧盟的医疗器械法规（MDR）。如果您参与医疗器械的设计和开发，并希望了解这一现行法规，希望您会觉得这系列视频有用。 内容简介：本系列将涵盖医疗器械法规（MDR）中涉及的多个主题，从什么算作医疗器械、关于这些器械的市场宣传声明的相关规则，到MDR的开发如何与国际统一标准相关联。我们将介绍作为设计师和制造商所需承担的许多义务，包括技术文档、可追溯性、风险管理等内容，并希望您能从中获益。在过程中，我们还将指引您如何找到每个主题的更多详细信息。 系列焦点：本系列更侧重于与设备设计和开发相关的MDR内容，尤其是在产品销售准备阶段，而不是分销、市场后的要求或通知机构的要求，尽管这些也是MDR中涉及的内容。 适用对象：无论您是刚刚进入医疗器械行业，还是希望更新自己对最新法规的了解，希望您能发现这个系列有用，并帮助您将学习提升到新的水平。
Welcome to this short video series introducing the European Union's Medical Device Regulation (MDR). If you're involved in the design and development of medical devices and are looking to get up to speed on this current regulation hopefully you'll find this series useful.What's InWe run through a lot of the topics covered in the MDR starting at what specifically count as medical devices, what rules govern the marketing claims which can be made about them and how development for the MDR relates to international harmonised standards. We introduce a lot of the obligations placed on us as designers and manufacturers including technical documentation, traceability, risk management and a lot of other content I hope you'll find useful. We also signpost where you can find more detail on each topic as we go along.What outIn this series, we focus more on aspects of the MDR relevant to design and development of devices in preparation for sale rather than, distribution, post market requirements, or the requirements placed on notified bodies which are also covered in the MDR.Who's it for?Whether you're just getting started in the medical device industry or looking to get up to date on this latest regulation, hopefully you will find this series useful and it will help take your learning to the next level.
