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所在平台: Udemy |
课程主页: https://www.udemy.com/course/eu-medical-device-regulation/
课程评论：没有评论
**欧洲医疗器械监管基础（Coursera课程总结）** 本课程将为您提供欧洲联盟（EU）医疗器械监管的入门级概述。您将了解欧盟政府如何制定控制医疗器械审批的法律法规。 课程涵盖三个主要方面： 1. **欧盟的政府结构：** 了解欧盟的治理框架，为理解其监管体系奠定基础。 2. **欧盟医疗器械指令：** 深入探讨与医疗器械相关的现行欧盟指令，了解其核心内容和要求。 3. **技术文件/设计文件结构：** 学习提交用于器械审批的技术文件或设计文件的构成要素。 本课程适合对欧盟医疗器械监管没有任何了解的初学者。完成课程后，您将从监管角度清楚地知道如何推进您的欧盟医疗器械项目，并了解如何获取关于您所需器械审批的进一步学习资源。
This is a bare basics overview of how medical devices are regulated in the European Union (EU). You will learn how the EU government creates laws and regulations that control medical device approvals there.The course covers three main areas:1) Governmental structure of the EU2) The EU Directives that deal with medical devices3) The structure of a Tech File/Design Dossier which is submitted for a device.The course is intended for those with no knowledge of device regulation in the EU. After taking this course, you will understand where to go next with your EU device project, from a regulatory standpoint, and you will know how to gain additional learning for your desired device approval.
