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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