Join this 3-day online workshop on using ASME V&V40 & FDA guidance for reliable medical device modelling & regulatory reporting.

Day 1: 28th June 2024, 4pm - 6pm BST

ASME V&V40-2018 Training (Jeff Bischoff, Zimmer Biomet, Senior Director, Research; Marc Horner, Ansys, Distinguished Engineer; Payman Afshari, Johnson & Johnson, Senior Principal Engineer; Linda Knudsen, Zimmer Biomet, Principal Engineer, Research)

A review of the risk-informed credibility assessment framework introduced in the ASME V&V40-2018 standard will be provided, highlighting the concepts of context of use, model risk, and model credibility. Several unique device examples will be used to illustrate how these concepts can be applied in practice in support of medical device development.

Day 2: 1st July 2024, 4pm - 6pm BST

FDA CM&S Credibility Guidance Training (Pras Pathmanathan, US Food and Drug Administration, Senior Scientist)

This session will provide an overview of the recently published FDA Guidance “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”. The guidance is closely related to the ASME V&V40-2018 Standard and provides a general framework for risk-informed credibility assessment of computational modeling. It is applicable to any physics-based or mechanistic (i.e., first principles-based) computational model, and any medical device regulatory application of these models.

Day 3: 2nd July 2024, 4pm - 6pm BST

FDA CM&S Reporting Guidance Training (Kenneth Aycock, FDA, Research Scientist)

This session will review recommendations for reporting CM&S evidence from two FDA guidance documents, “Reporting of Computational Modeling Studies in Medical Device Submissions” (2016) and “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” (2023). The scope, contents, and reporting outlines form each will be compared to clarify appropriate scenarios for using one or both documents to support CM&S reporting.