|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/project-management-for-medical-devices/
课程评论：没有评论
**课程名称：** 医疗器械项目管理 **课程概述：** 本课程旨在填补市面上项目管理（PM）和医疗设备开发（MDD）课程之间的空白。市面上的项目管理课程多为通用型或专注于特定行业（如建筑、软件开发），而专门针对医疗器械开发的课程却寥寥无几。 本课程将通过视频讲座和幻灯片，教授项目管理最佳实践与医疗器械开发的“设计控制”的结合。学员将了解当代医疗器械开发流程（设计控制）如何融入项目管理协会（PMI）的公认项目管理方法。 课程将首先简要介绍项目管理和医疗器械的概念，然后深入讲解公认的项目管理过程，并将其应用到符合美国食品药品监督管理局（FDA）法规 21 CFR 820.30（规范医疗器械）的设计控制等效环节。最后，课程将介绍适用于医疗器械开发的关键项目管理知识领域，并引入一些新的知识领域，如“法规”。 **适用人群：** * 直接或间接参与医疗器械开发项目的专业人士。 * 需要了解该领域基础知识的新入职工程师和项目经理。
Courses in Project Management (PM) abound both in the classroom and online. However, nearly all currently available courses focus either on generic PM or specific industries such as construction and software development. There is a decided lack of PM courses that address medical device development (MDD). Enter this course.Through a series of video lectures and slides, this course will tackle the combination of best practices in PM and design controls for MDD. Students will understand how the contemporary MDD process (design controls) fits into the accepted method for PM taught by the Project Management Institute. After a brief definition of PM and medical devices, the course will step through the accepted PM Processes and apply them to the equivalent steps taken in Design Controls as per regulation 21 CFR 820.30, which governs medical devices. Next, the course will describe key PM Knowledge Areas appropriate for MDD and introduce some new ones, such as Regulatory.Medical device professionals dealing with development projects either directly or indirectly can benefit from this course, as well as newly hired engineers and project managers that need a basic introduction to the field.
