Regulatory Affairs Minor

The Regulatory Affairs Minor covers FDA regulations, laws and regulatory document processes related to medical devices, medical device development, and project/facility management. The program provides students with an understanding of applications such as obtaining approval for medical devices, pharmaceuticals, and biologics, and marketing and implementing medical devices in hospital/clinical settings. The minor prepares students particularly for careers in regulatory affairs, but also for the healthcare industry in general.

Students majoring in biomedical engineering can count no more than 9 hours from their major towards this minor. Students may not receive both the clinical engineering and regulatory affairs minors.

Program Requirements

Required Courses
CPB 448Hospital Rotation3
CPB 402Introduction to Clinical Engineering3
CPB 452Introduction to FDA Regulations and Medical Device Laws3
CPB 453Medical Device Development and Regulatory Considerations3
Select two from the following:6-7
Quality Management Systems
Introduction to Programming and Scripting for Data Analytics
Applied Statistics
Statistics
Medical Terminology
Medical Terminology for Health Professionals
Medical Ethics
Health Care Informatics
Biodynamics of Human Performance
Health Information Technology I
Medical Sociology
Challenges in Health Care Delivery
U. S. Health Care System and Culture
Engineering Principles in Medical Device Design
Bioinstrumentation
Sensors and Data Fusion with Robotics Applications
Design and Modeling of Robotic Systems
Digital Signal Processing
Biomedical Signal Analysis
Digital Image Processing
Machine Learning
Bioinformatics Computing Skills
Image Processing & Computer Vision
Select one from the following:3
Leading and Managing Projects
Introduction to Management & Leadership
Introduction to Operations and Supply Chain Management
Total Credit Hours21-22