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所在平台: Udemy |
课程主页: https://www.udemy.com/course/advanced-medical-device-development/
课程评论：没有评论
课程名称：高级医疗器械开发 课程概述：该课程是医疗器械开发的延续，涵盖了医疗器械在“设计冻结”前后的主要事件，直至临床评估和商业发布。课程重点强调质量体系和制造过程，同时关注监管和法律合规性以及设计概念。课程首先补充了美国监管知识，介绍了欧盟医疗器械监督的基础知识，特别是医疗器械法规（MDR）和体外医疗器械法规（IVDR）。接下来讨论设计后的活动，如完成设计历史文件的建设和商业化的初步步骤。一旦设备进入市场，通常需要对制造过程和设备本身进行更改。课程介绍了实施这些更改和验证新流程的方法。最后，课程深入探讨了与产品管理和临床试验相关的市场后活动，详细介绍了进行人体研究所需的法规，以及产品经理在整合各项活动中的角色。
This course is a continuation of Medical Device Development. Topics cover the primary events that occur from just before "design freeze" of a medical device up through clinical evaluation and commercial launch. Significant emphasis is placed on Quality Systems and Manufacturing, with attention to regulatory and legal compliance as well as design concepts.The course begins by supplementing already existing US Regulatory knowledge with the basics of medical device regulation in the EU, specifically the Medical Device Regulation (MDR) and In Vitro Devices Regulation (IVDR). This discussion then carries on to post-design activities, such as finishing construction of the Design History File and the first steps of commercialization. Once the device has entered to market, changes are often required to the manufacturing process and the device itself. Methods for enacting these changes and validating the resulting new processes are discussed.Finally the course ends with a deep discussion on post-market activities in relation to Product Management and clinical trials. The necessary regulations for running human studies are covered in detail, along with a description of the Product Manager's role in making the activities come together.
