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Certificate in Regulatory Affairs (16-18 credits)


Program Student Learning Outcomes

  • Synthesize principles of medical device regulatory requirements, investigational device exemptions, regulatory submissions and compliance in a global society.
  • Use principles of experimental design, sample size estimation, and analysis methods to draft clinical trial protocols.
  • Assess quality system standards, procedures, and practices.
  • Apply economic principles of the health care market, including cost management and reimbursement for medical technology.
  • Present technical information and analysis in both oral and written forms.






The contents in this catalog and other university publications, policies, fees, bulletins or announcements are subject to change without notice and do not constitute an irrevocable contract between any student and St. Cloud State University.