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 
653
Bioinnovation I (instructor approval required to join course) 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
BMEN
406/606
Medical Device Path to Market
OR
3
BMEN
469/669
Entrepreneurial Issues in Biomedical Engineering 3
ISEN
350
Quality Engineering
OR
3
ISEN
614
Advanced Quality Control 3
Prefix & 
Number 
Prescribed Elective Courses (Choose 0-1)SCH
BMEN
654
Bioinnovation II 3
ISEN
414
Total Quality Engineering 3
ISEN
434
Human Error & System Failures 3
MMET
418
Medical Manufacturing 3
VTMI
629
Laboratory Quality Systems 3


Notes:

Students may choose no more than one course from each line below to satisfy the certificate requirements
  • BMEN 404/604
  • BMEN 406/606/469/669
  • ISEN 350/614


For more information

Maria Lyons
Academic Advisor III
Biomedical Engineering
3120 TAMU
College Station, TX 77843-3120

Email: bmen@tamu.edu
Phone: 979.845.2312