Regulatory Science Symposium: Clinical Trials with Medical Devices Session 5: Medical Device Feasibility Clinical Trials – SetPoint Medical Case Study (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.


  1. SetPoint Medical Overview
  2. SetPoint System
  3. Feasibility Study Design
  4. Key Objectives
  5. Study Stages
  6. Site Selection and Activation
  7. Investigator and Study Staff Training
  8. Screening and Enrollment
  9. Monitoring
  10. Study Closeout


Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy |

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