Course schedule for the Quality Systems Certificate Program, Northwestern University School of Professional Studies - Northwestern School of Professional Studies

Course Schedule

Below you will find a listing of courses. You can narrow your course search by day, location or instructor.

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.