Demystifying the FDA’s Human Factors Guidance

As part of FDA approval, a new medical device must follow guidelines for “Human Factors,” which address design and encompass usability and ergonomics. Because medical devices are so diverse, manufacturers often struggle to understand how the guidelines apply to their own product. At this talk, Dr. Russell Branaghan, Founder/President at Research Collective will describe strategies to help companies (1) improve their time to market and overall design through early implementation of human factors, and (2) pass their human factors validation test for FDA clearance.