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 career, candidates for this certificate are expected to be entering a high-growth job market for engineers.

For additional information, contact the Quality Engineering for Regulated Medical Technologies Certificate coordinator at bmen@tamu.edu.

Course List

Code	Title	Semester Credit Hours
Required Internship
Select one of the following:		3
Internship (must be approved by certificate faculty to meet experience needs)
Bioinnovation I-Summer Clinical Fellowship
Required Courses
Select two or three from the following:		6-9
BMEN 404	FDA Good Laboratory and Clinical Practices
BMEN 406	Medical Device Path to Market
or BMEN 469	or Entrepreneurial Pathways in Medical Devices
ISEN 350	Quality Engineering
Elective Courses
Select up to one of the following:		0-3
ISEN 414	Total Quality Engineering
ISEN 434	Human Error and Resilient System Design
MMET 418	Medical Manufacturing
Total Semester Credit Hours		12