Technology Assessment and Regulation of Medical Devices

1 credits · Graduate

Regulatory approval and reimbursement for new medical technologies as a key component of product commercialization. The regulatory and payer environment in the U.S. and abroad, and common methods of health technology assessment. Framework to identify factors relevant to adoption of new medical devices, and the management of those factors in the design and development phases. Case studies; guest speakers from government (FDA) and industry.