Skip To Main Content

Quality Engineering for Regulated Medical Technologies

Quality engineering principles are mandated by federal and state regulations for clinical facilities and for the design, testing and manufacture of medical technologies (such as pharmaceuticals and imaging, diagnostic and therapeutic devices). Completion of this certificate requires specific instruction in quality engineering and regulation of medical technologies; moreover, candidates must go beyond understanding concepts and demonstrate appropriate usage of quality engineering principles in a medically related internship. Given the challenging demands for both better outcomes and lower costs in medical care, candidates for this certificate are expected to be entering a high-growth job market for engineers.

Course Requirement Summary

Prefix &
Number
Required Internship (Choose 1) SCH             
BMEN 
484
Internship (position must be approved by certificate faculty to meet experience needs) 3
XXEN
399/485
Internship (position must be approved by certificate faculty to meet experience needs) 3
XXEN
684
Internship (position must be approved by certificate faculty to meet experience needs)
Prefix &    
Number    
Required Courses (Choose 2-3) SCH  
BMEN
404/604
FDA Good Laboratory and Clinical Practices   3
ISEN
414/614
Total/Advanced Quality Engineering 3
ISEN
350
Quality Engineering 3
Prefix & 
Number 
Prescribed Elective Courses (Choose 0-1) SCH
BMEN
643
Risk Based Development and Testing of Medical Devices  4
BMEN
469/669
Entrepreneurial Issues in Biomedical Engineering 3
ISEN
434/671
Human Error & System Failures 3
MMET
418
Medical Manufacturing 3
VTMI
629
Laboratory Quality Systems 3

To apply or for more information

Jacob Clough

  • Academic Advisor III
  • Undergraduate Advisor
Jacob Clough