Medical Device Regulation (Graduate Certificate)

Medical Device Regulation (Graduate Certificate)

Requirements and Details

Program
Requirements

Complete admission and program requirements are found in the University Catalog.

Program Track

Fall Semester

  • RAS 621 (3 cr) Legal Basis for Medical Device Product Regulation OR MTQ 620 (3 cr) Medical device Quality and Regulatory Fundamental 
  • RAS 633/MTQ 626 (3 cr) Quality Systems for Reguated Industry
  • *Electives:
  • ACR-620 (4 cr) Applied Anatomy, Physiology & Pathophysiology
  • ACR-622 (2 cr) Lifecycle of the Clinical Product
  • ACR-641 (1 cr) Fundamentals of Leadership

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.