In early January the Center for Devices and Radiological Health held a webinar on the new Final Guidance document focused on credibility of computational models for medical devices.
This webinar discusses the final guidance document which was issued on November 16, 2023. This guidance provides a general risk-informed framework that can be used in the credibility assessment of computational modeling and simulation, or CM&S, used in medical device regulatory submissions.
During the webinar FDA - discussed how manufacturers can use the guidance to show that computational models used to support regulatory submissions are credible; provided recommendations for using the FDA-recognized standard from the American Society of Mechanical Engineers V&V 40, titled Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices, to show CM&S credibility, and answered questions about the final guidance.
The video is now available here
