Medical Technology Regulatory. (3-0) 3 Credit Hours

Catalog description

Prerequisite: Graduate standing, consent of the instructor and of the Graduate Advisor of Record, and BME 6123 . This course provides an overview of product quality and safety responsibilities during device development, the regulatory framework, both nationally as well as internationally, and product monitoring standards. An understanding of the approval submission process and the nature of benchmarking and testing products as well as product classifications will be covered. This course has Differential Tuition.