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
Code | Title | Credit Hours |
---|---|---|
Required Courses | ||
CPB 448 | Hospital Rotation | 3 |
CPB 402 | Introduction to Clinical Engineering | 3 |
CPB 452 | Introduction to FDA Regulations and Medical Device Laws | 3 |
CPB 453 | Medical Device Development and Regulatory Considerations | 3 |
Select two from the following: | 6-7 | |
Quality Management Systems | ||
Introduction to Programming and Scripting for Data Analytics | ||
Applied Statistics | ||
or STA 261 | Statistics | |
Medical Terminology | ||
Medical Terminology for Health Professionals | ||
Medical Ethics | ||
NSG 343 | ||
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 and Machine Learning | ||
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 Hours | 21-22 |