BMEN 4312 - FDA Regulations and Quality Control of Biomedical Systems
3 hours Introduction to regulations and best practices recommended by the US Food and Drug Administration (FDA) that pertain to testing and marketing of biomedical devices and systems. Discussion on implementation of best practices for pre-clinical and clinical studies. Introduction to total quality engineering and total quality management as related to medical devices and systems. Building quality into design of products and systems in biomedical engineering.
