RGA 6400 — Medical Device Product Development and Process Validation
2 semester hoursGraduateLecture
Explores essential concepts, methodologies, and regulatory frameworks associated with validating manufacturing processes in the medical device industry. Focuses on a holistic understanding of these processes, methodologies, and regulations. Offers students an opportunity to gain the expertise needed to contribute effectively to producing safe, high-quality medical devices, while ensuring regulatory compliance, by delving into industry best practices, regulatory requirements, and risk-based strategies.