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所在平台: Udemy |
课程主页: https://www.udemy.com/course/european-medical-device-regulation/
课程评论：没有评论
**课程名称：欧盟医疗器械法规事务简明解释** **课程概述：** 本课程以简洁易懂的方式讲解欧盟医疗器械法规。学员将逐步了解公司如何获得在欧洲销售医疗器械的许可。本课程适合希望从事医疗器械监管、参与医疗器械初创企业，或在运营、质量、工程、市场营销及研发领域进入医疗器械行业的人士。如果您想了解在欧盟市场销售医疗器械的规则，或作为欧盟以外的医疗器械制造商希望在欧洲销售产品，本课程都将是理想选择。您将深入理解 ISO 13485:2016 标准在获得市场准入方面的重要性。 **课程内容涵盖：** * 法规与指令的区别 * 在欧洲生产和销售医疗器械所需的步骤 * 主管当局 (Competent authority) * 公告机构 (Notified body) * **主动植入式医疗器械指令 (MDD 90/385/EEC)** * **医疗器械指令 (MDD 93/42/EEC)** * **体外诊断医疗器械指令 (MDD 98/79/EEC)** * **新版法规：欧盟医疗器械法规 (MDR EU 2017/745) 及欧盟体外诊断医疗器械法规 (IVDR EU 2017/746)** * CE 标志审批流程 * 医疗器械分类，包括 MDR 2017/745 的分类 * **ISO 13485:2016 标准** * 其他关键方：制造商、授权代表 (Authorized representative) 和欧洲自由贸易联盟 (EFTA) * **英国脱欧 (Brexit) 对欧盟法规的影响** * **从指令到医疗器械法规的过渡时间线** **学习评估：** 每堂课都设有测验，帮助学员巩固学习成果并达成课程学习目标。
Each lecture is explained in simple format. If the student takes each lecture step by step, they will understand how a company gains permission to manufacture a medical device which will be allowed to be sold in Europe. This module is ideal for a person who wants to work in medical device regulation, who wants to be involved in a medical device start up or who wants to be involved in the medical device industry either in operations, quality, engineering, marketing and research/development. If you are a student who wants to understand the rules that govern the sale of medical devices in the European Union Market place this course is perfect for you. If you are a medical device manufacturer outside the European Union and would like to sell your product in Europe this course is ideal for you. You will understand how important the ISO 13485 2016 standard is to gain market approval. The following topics will be covered:´Difference between Regulation and a Directive.´Steps required to get permission to manufacture and sell a medical device in Europe.´Competent authority´Notified body.´MDD 90/385/EEC Active Implantable Medical Device Directive.´MDD 93/42/EEC Medical Device Directive.´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices.´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).´CE Marking approval process.´Classification of medical device. Including the MDR 2017 745 classification. ´ISO 13485 2016´Other players the Manufacturer, the Authorized representative and the EFTA.Each lecture has a quiz that will enable students to understand the learner outcomesBrexit understand the impact to the European Union regulation. Understand the transitional time lines from the directives to the medical device regulation.
