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 | ||
| 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 | |
