Presentations From the Training Session at the 2024 FDA/MDIC Symposium on Computational Modeling and Simulation
Description
Presentations from the half-day pre-symposium training session at the FDA/MDIC Symposium on Computational Modeling and Simulation, 2024 (https://mdic.org/event/mdic-symposium-on-computational-modeling-and-simulation/)
Three talks were presented, providing training on three documents, the ASME V&V40 Standard and two FDA Guidance documents.
1. "ASME V&V40 - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices", 2018, https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices
2. FDA, "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions", 2023, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions
3. FDA, "Reporting of Computational Modeling Studies in Medical Device Submissions", 2016, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-computational-modeling-studies-medical-device-submissions