Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium.

Abstract

Computational modeling and simulation (CM&S) is a powerful tool that can be used to support the development, evaluation, and regulatory authorization of medical devices. CM&S can provide valuable insights into device performance, safety, and effectiveness, as well as reduce the need for animal or human testing. Computational models are, however, idealized digital representations that often have many assumptions and need to be credible before they are used in decision making that could incur pati