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BENG6350

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BENG6350 - Medical Device & In-Vitro Diagnostic Substance Manufacturing - 3 - Credits

Biological EngineeringCollege of Engineering
Course OverviewCourse Learning Objectives

Course Learning Outcomes

  1. Understand the classification of medical device

  2. Describe regulatory pathways for medical device and diagnostic approval

  3. Apply design control and risk management principles to product development

  4. Evaluate quality and validation requirements for manufacturing and testing

  5. Assess compliance strategies for global device markets

  6. Communicate with industry partners to receive training from SMEs in this field