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所在平台: Udemy |
课程主页: https://www.udemy.com/course/medical-devices/
课程评论：没有评论
**课程名称：** 医疗器械法规 **课程概述：** 医疗器械行业正在快速发展，为创新者、专家和创业者提供了巨大的机遇。本课程将全面介绍新设备从概念到产品的全过程，帮助您深入了解这个复杂且快速变化的商业领域。我们将涵盖将新设备推向市场的所有关键组成部分，包括： * **上市路径：** 重点介绍510(k)豁免、上市前批准（PMA）、人道主义器械豁免（HDE）以及其他常用的上市途径。 * **医疗器械临床试验：** 包括器械豁免（IDE）的提交、记录和报告。 * **风险管理与质量：** 探讨在器械开发过程中的风险管理和质量控制。 此外，本课程还将介绍公开可用的信息来源，帮助您研究器械公司并了解其价值。我们将讲解医疗器械数据库，使您能够研究已上市的医疗器械；以及临床试验数据库，帮助您了解已规划和正在进行的医疗器械临床试验。课程中将提供这些免费资源的链接。 **目标学员：** 本课程对于任何希望发展基础医疗器械行业知识的人都极具价值。 * **医械工程专业的学生和近期毕业生：** 帮助您了解行业知识，以及公司将新创新推向市场所依赖的监管步骤。 * **项目经理：** 帮助您学习了解该行业，并为管理医疗器械开发项目做好准备。 * **相关领域的专业人士：** 为您提供医疗器械行业的概览。
The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space. We will cover all of the key components of bringing a new device to market, including:Paths to Market, including the 510K, PMA, HDE and other commonly used pathwaysClinical trials of medical devices, including IDE, submissions, records and reportingRisk management and quality in device developmentDuring this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.
