Control of Medical Device Use-Related Risks

Name: Control of Medical Device Use-Related Risks
Start: 2025-09-08T16:30:00+01:00
End: 2025-09-08T16:30:00+01:00

About

Join former FDA expert Ron Kaye for a five-session online course on navigating FDA premarket review and effectively managing medical device use-related risks. Gain deep insights into what use-related risk really means, the true nature of use error, and why context matters—whether during testing or in real-world use. Ron will demystify often ambiguous Standards and Guidance, and show how to generate project-specific, regulatory-grade data. Learn essential risk terminology for usability, what human factors testing must answer, and how to build clear, compelling reports. Explore the value of formative testing and avoid common industry pitfalls. This is a rare opportunity to learn directly from someone who’s been on the inside of FDA reviews—don’t miss it.