Quality Engineering for Regulated Medical Technologies - Certificate

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.

Required Course in Regulatory Affairs
Select one of the following:3
FDA Good Laboratory and Clinical Practices (Medical Device Testing)
FDA Good Laboratory and Clinical Practices (Medical Device Testing)
Medical Device Path to Market
Medical Device Path to Market
Medical Device Regulation
Global Medical Device Regulation
Design of Medical Devices
Design of Medical Devices
Required Course in Quality
Select one of the following:3
Statistical Control of Quality
Total Quality Engineering
Advanced Quality Control
Required Internship
Select one of the following:3
XXEN 485
Internship (position must be approved by certificate faculty to meet experience needs)
XXEN 684
Internship (position must be approved by certificate faculty to meet experience needs)
Prescribed Elective Courses 1
Select one of the following:3
FDA Good Laboratory and Clinical Practices
FDA Good Laboratory and Clinical Practices (Medical Device Testing)
Clinical Engineering
Medical Device Regulation
Global Medical Device Regulation
Design of Medical Devices
Design of Medical Devices
Statistical Control of Quality
Total Quality Engineering
Advanced Quality Control
Design and Analysis of Industrial Experiments
Laboratory Quality Systems
Total Semester Credit Hours12
1

Choice cannot be a course used to satisfy the required courses, and both the undergrad and grad versions of the same course cannot be used, e.g. BMEN 404 and BMEN 604 cannot both count towards fulfilling requirements.