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所在平台: Udemy |
课程主页: https://www.udemy.com/course/fundamentals-of-medical-devices/
课程评论：没有评论
课程名称：医疗器械基础知识 课程概述：本课程提供了医疗器械监管环境的综合介绍。涉及的重要主题包括设备分类、监管框架、临床评估、质量管理系统和上市后监测。参与者将获得关键监管要求和流程的实用见解，确保在主要全球市场中的合规性。 适合人群： - 医疗器械行业的新专业人士 - 从其他行业转型的监管事务专业人士 - 质量保证和合规人员 - 研发工程师和项目经理 - 对医疗器械监管方面感兴趣的医疗专业人士 - 希望掌握医疗器械法规基础知识的任何人 学习成果：通过本课程，参与者将能够： 1. 理解医疗器械的监管分类。 2. 理清全球主要监管框架，包括欧盟医疗器械法规（EU MDR）和FDA规定。 3. 制定和维护技术文档和质量管理系统。 4. 为监管提交和市场准入做好准备。 课程大纲： 1. 医疗器械简介 - 定义和实例 - 器械与药品的区别 2. 监管框架 - 全球法规概述 - 主要监管机构 3. 设备分类 - 分类标准和实例 - 基于风险的分类 4. 符合性评估与CE标志 - 通知机构及其角色 - 获得CE标志的步骤 5. 技术文档 - 必要组件 - 准备技术文件 6. 质量管理系统（QMS） - ISO 13485概述 - QMS实施 7. 监管提交与批准 - 主要市场的提交流程 - 与监管当局的互动 通过该课程，参与者将全面了解医疗器械的监管要求以及如何在全球市场中确保合规。
This course offers a comprehensive introduction to the regulatory landscape for medical devices. It covers essential topics such as device classification, regulatory frameworks, clinical evaluation, quality management systems, and post-market surveillance. Participants will gain practical insights into the key regulatory requirements and processes necessary for compliance in major global markets.Who Should Attend?This course is ideal for:- New professionals in the medical device industry.- Regulatory affairs professionals transitioning from other industries.- Quality assurance and compliance personnel.- R & D engineers and project managers.- Healthcare professionals interested in regulatory aspects of medical devices.- Anyone seeking a foundational understanding of medical device regulations.Learning Outcomes:By the end of this course, participants will be able to:1. Understand the regulatory classification of medical devices.2. Navigate key global regulatory frameworks, including EU MDR and FDA regulations.3. Develop and maintain technical documentation and quality management systems.4. Prepare for regulatory submissions and market access.Outlines:1. Introduction to Medical Devices- Definition and examples- Device vs. pharmaceuticals2. Regulatory Frameworks- Overview of global regulations- Key regulatory authorities3. Device Classification- Classification criteria and examples- Risk-based classification4. Conformity Assessment and CE Marking- Notified Bodies and their roles- Steps to obtain CE marking5. Technical Documentation- Essential components- Preparing a technical file6. Quality Management Systems (QMS)- ISO 13485 overview- QMS implementation7. Regulatory Submissions and Approvals- Submission processes for major markets- Interactions with regulatory authorities
