Medical device regulations

Catalog description

Design control is critically important in biomedical engineering, particularly when developing medical devices, diagnostics, and other health-related products. It is a structured process mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA) to ensure that medical products are designed to meet user needs, are safe and effective, and comply with regulatory requirements. Topic for this course will include medical device classification, introduction to Current good manufacturing practice (CGMP), introduction to quality management system (QMS) for medical devices, medical device classification, principles and requirements of design controls, including design and development planning, design input, design output, design verification, design validation, design transfer, and design changes Classroom Hours - Laboratory and/or Studio Hours – Course Credits: 3-0-3