Project Management for Medical Devices

Merging solid project management concepts with medical device development

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.