ETI 1030 REGULATORY ENVIRONMENT FOR MEDICAL DEVICES 3 credits

This course will provide an understanding of the basics of the Food and Drug Administration (FDA) regulation and compliance for medical devices including how the various activities within a medical device company are affected by the FDA regulations. Additional coverage will include the applicable laws and regulatins enforced by the FDA;  international standards and regulations; the regulations controlling medical device design and development; the medical device approval process; laboratory and clinical studies; the introduction to the Quality System Regulations (QSRs); and the FDA inspection process. 47 contact hours.