BME 11553Regulatory Strategies in Biomedical Engineering

Catalog

This course examines domestic and foreign regulatory practices associated with biomedical devices and/or products. It will cover the processes and protocols used by the FDA in order to better prepare students to be significant contributors to the development of a biomedical product that meets or exceeds all the applicable standards, regulations, and laws that apply to its applicable technology. Students will examine regulatory strategy for specific medical devices and products.