Program Courses
Please note that course schedules may be amended due to low enrollment, faculty availability, and/or other factors.
Online Sync Sessions are an integral part of the online learning experience. Additional information about learning concepts and assignments may be discussed and sync sessions offer valuable opportunities for students to interact with their faculty and peers during the term. We encourage all students to attend live, but if they are unable to, sync sessions will be recorded and posted within Canvas to allow for an asynchronous model of success as well.
QARS 450-DL : Medical Device Regulations
Description
This course will provide an analysis of global medical device development and approval requirements, concentrating on the preparation of global medical device strategies. The course will cover the medical device classification and regulation by ministries of health around the world. FDA regulation of medical devices including Investigational Device Exemption (IDE), 510(k), and PMA will be taught as a foundation for looking at global regulatory submission pathways. In addition to FDA regulations, this course will cover medical device regulations for the European Union, Canada, and other major markets. Additionally, students will be exposed to common post-market challenges such as change control and import/export issues. Completing this course will position you to apply for first-tier regulatory professional job opportunities specific to medical devices, as well as new product development and managing products on the market from a regulatory perspective.
Quality Systems and Clinical Research track course.