Medical Device Regulation (Graduate Certificate)
Requirements and Details
Complete admission and program requirements are found in the University Catalog.
- RAS 621 (3 cr) Legal Basis for Medical Device Product Regulation OR MTQ 626 (3 cr) Medical Technology Quality Systems
- RAS 633/MTQ 620 (3 cr) Medical Device Quality and Regulatory Fundamentals
- ACR-620 (4 cr) Applied Anatomy, Physiology & Pathophysiology
- ACR-622 (2 cr) Lifecycle of the Clinical Product
- ACR-641 (1 cr) Communication for MedTech Professionals
- RAS 631 (4 cr) IDE Regulations and Clinical Trial Design
- RAS-623 (3 cr) Regulatory Routes to market: 510(k)s
- RAS-635 (3 cr) Regulatory Affairs Compliance
- MTQ-622 (3 cr) Quality Engineering
- MTQ-628 (4 cr) Design Control and Product Development
- MTQ-634 (3 cr) Corrective and Preventive Action (CAPA)
- MTQ 624 (3 cr) Risk Management (summer semester)
*Electives: Select 3-4 credits with adviser.