BMEN 5175 - Medical Device Clinical Requirements

3 hours

Focuses on the clinical evidence needed for regulatory submissions in both the USA and Europe for medical devices. Review of requirements needed to conduct a clinical trial, documentation needs, and ethical considerations. Also reviews requirements needed for clinical evidence, literature searches and requirements for post-market surveillance. Final project to include a case study on a post-market surveillance report.

Prerequisite(s): Graduate student in Biomedical Engineering or permission of instructor, Introduction to FDA Quality and Regulatory Affairs

Course specific fees (in addition to tuition and mandatory):
Academic (AF) per hour: $73.70