Quality Engineering for Regulated Medical Technologies - Certificate

Quality engineering management systems are mandated by federal and state regulations for the design, testing, and manufacture of medical technologies (such as pharmaceuticals, imaging technologies, medical diagnostics, and therapeutic devices). Different and complimentary quality regulations apply to both clinical and pre-clinical facilities involved in testing and validating new technologies. Completion of this certificate requires specific instruction in both quality engineering and regulation of medical technologies; moreover, candidates must go beyond understanding concepts by demonstrating appropriate use of quality engineering principles in a medically-related internship. Given the challenge to achieve both improved outcomes and lower costs in medical care, candidates for this certificate are expected to be entering a high-growth job market for biomedical engineers.

Required Internship
Select one of the following:3
Internship (position must be approved by certificate faculty to meet experience needs)
Bioinnovation I-Summer Clinical Fellowship
Required Courses
Select from the following:6-9
FDA Good Laboratory and Clinical Practices
Medical Device Path to Market
   or Entrepreneurial Pathways in Medical Devices 
Advanced Quality Control
Elective Courses
Select from the following:0-3
Risk Based Development and Testing of Medical Devices
Design and Analysis of Industrial Experiments
Laboratory Quality Systems
Total Semester Credit Hours12