FDA/MDIC Symposium on Computational Modeling & Simulation Generating Regulatory In Silico Evidence

Discover the latest innovations in computational modeling and simulation for developing in silico regulatory evidence. The FDA/MDIC Symposium on Computational Modeling and Simulation (CM&S), will take place in the Washington DC Metro Area, from April 16-17,2024. Co-organized by medical device industry leaders and FDA members of the MDIC Computational Modeling & Simulation Steering Committee, this event is designed to spearhead innovation and foster collaboration in the realm of computational modeling and simulation for the advancement of regulatory-grade evidence in the medical device industry.

What to Expect at #ModSim2024

    • Cutting-edge Training: Dive into the intricacies of model credibility assessment and the art of effectively presenting computational evidence in regulatory submissions to the FDA. Our expert-led sessions will provide invaluable insights into best practices and strategies to ensure your models meet the highest standards of credibility and reliability.
    • Explore Cutting-edge Applications: Explore the forefront of computational evidence application in both clinical and non-clinical domains, where industry leaders will unveil the latest innovations and breakthroughs shaping the future of medical device development and regulatory compliance.
    • Interactive Panel Discussions: Engage in dynamic panel discussions that foster an exchange of groundbreaking information and ideas. Discover how the industry can collectively advance computational modeling and simulation toward attaining regulatory-grade evidence, setting the stage for transformative advancements in bringing innovative devices to market.
    • Real-World Case Studies: Gain valuable insights from in-depth case studies showcasing successful approaches to assessing model credibility. Learn from practical examples that demonstrate how to navigate challenges and leverage opportunities in the computational evidence landscape.
    • Insights for Regulatory Decision Making: Acquire valuable perspectives on the pivotal role of modeling and simulation in the regulatory decision-making process. Uncover the potential of computational modeling and simulation in shaping the future of regulatory assessments and decision-making protocols.
    • Exhibition and Poster Sessions: Immerse yourself in a rich tapestry of innovation at the #ModSim2024 poster exhibits. Explore the latest tools, technologies, and advancements in computational modeling and simulation, showcasing the cutting-edge contributions of industry trailblazers and thought leaders.

CM&S Pre-symposium Workshop on April 15

Join us on Monday, April 15 for a half-day pre-symposium workshop as part of the FDA/MDIC Symposium on Computational Modeling and Simulation.

There will be three separate training sessions:
1. ASME V&V 40-2018 standard “Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices”
2. FDA Guidance on “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”
3. FDA Guidance on “Reporting of Computational Modeling Studies in Medical Device Submissions”

The training sessions will be taught by subject matter experts from the FDA and medical device industry. The courses will provide overviews of each topic and will highlight the key principles through medical device examples and interactive discussions. Register for the pre-symposium workshop to join colleagues and experts from FDA and industry for an opportunity to discuss important and timely topics in depth!

Meeting Date
Meeting Location
Hyattsville, Maryland
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