Medical Device Regulation and Standards

Catalog description

This course provides an overview of the regulatory processes and requirements for medical device development, with a primary focus on the Food and Drug Administration (FDA). It examines the regulatory framework for medical devices in the United States, including Quality Management Systems Regulation (QMSR), device classification, market authorization pathways, and the roles of premarket approval and postmarket surveillance. Key topics include the importance of standards and risk management in device regulation, as well as considerations for safety, effectiveness, and cybersecurity. Special emphasis is given to the regulation of AI-enabled medical devices, including the ethical responsibilities and societal implications associated with their development and deployment, such as algorithmic bias, equitable patient outcomes, data stewardship, and the impact of AI-driven clinical decision-making on patient safety and provider accountability. The course also explores the clinical evaluation of medical devices, focusing on clinical trial requirements and regulations, along with the fundamentals of healthcare economics and insurance reimbursement processes in the United States. Applied AI Integration: This course meets or exceeds MSOE’s Applied AI Integration guidelines for substantial coverage of Social Responsibility.