Medical Device Design Project I

Catalog description

Prerequisite or co-requisite(s): ME 3400 . First course in problem-based learning series that demonstrates steps necessary to take medical device projects from conception to market from an engineering perspective. Focus on Phase 1: medical device design requirements, including problem identification, patent searches, literature reviews, FDA requirements, premarket approval applications, investigational device exemptions, and premarket notification. Project management taught in relevant context from developing PM software skills to evaluating “what if” scenarios for possible future outcomes.