Medical Device Development Immersion is a course designed for those who need to better understand all aspects of medical device development. Beginning with an overview of the medical device industry, the course quickly delves into the changing regulatory environment and the different regulatory pathways devices can undertake for FDA or EMA marketing approval. Attention is then focused on a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course ends with a brief look at commercialization, including reimbursement strategies. Learn from an industry expert with 30-years of experience in both large and start-up medical device companies. This is a recording of a Medical Device Development Immersion course given live.
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05 Week 4: Phase I: Market Opportunity Evaluation
06 Week 5: Phase II: Concept Evaluation
08 Week 7: Phase IV: Verification & Validation
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- Complete course activities
- Complete course evaluation