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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.

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