The Role of Computational Modeling in the Regulatory Review of Medical Devices- Brent Craven

Description

This transcript is from a presentation on the regulatory aspects of medical device modeling and simulation, particularly focusing on guidance from the FDA. The speaker begins by declaring no conflicts of interest and smoothly transitions into discussing the modeling and simulation's roles in medical device safety and effectiveness evaluation. Key topics include the importance of compliance with FDA reporting guidance, the need for credible assessment frameworks for modeling simulations, and the types of evidence that can be used to establish the credibility of these models. The discussion culminates in emphasizing the evolution of assessment methodologies to encompass emerging technologies like AI and machine learning. The speaker concludes by inviting questions, indicating engagement and readiness to address audience queries.

Specialties

Conferences