Requirements and Details

Program Track

Fall Semester

• 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

• *Electives:
• 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

Spring Semester

• RAS 631 (4 cr) IDE Regulations and Clinical Trial Design

• *Electives:
• 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)

Summer:

• MTQ 624 (3 cr) Risk Management (summer semester)

*Electives: Select 3-4 credits with adviser.