BMEN 5150 - Medical Device Marketing and New Product Integration

3 hours

Medical device regulatory strategy for the U.S. and other countries, to allow products to be marketed. Deeper dive into design and development for new products, including regulatory strategy, quality plan, design development inputs and outputs, clinical considerations, design verification and validation, etc. Includes a walk-through of the phase-gate approach to design development that is utilized in industry. Final project to include a case study developing design history file documentation, including regulatory strategy.

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