Overview of the Program:

Paving the way for evaluation of 21st-century medical devices

The MDIC Computational Modeling and Simulation Project was developed to achieve the delivery of medical product solutions in a responsible, patient sparing way. Through the use of computational modeling and simulation as valid scientific evidence, this effort balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty.

The following seven priority areas were identified for the initial focus of the Computational Modeling and Simulation steering committee:

    • Combining simulations and experiments to inform clinical trials.
    • Simulation of the heart, vasculature, and related medical devices.
    • Neurostimulation electrochemical mechanisms of damage identification.
    • Magnetic resonance-induced heating.
    • Modeling and simulation in orthopedics.
    • Libraries for publicly sharing models, inputs, and validation data.
    • Simulation of blood damage, hemolysis, and thrombosis.

Program Background

The MDIC Computational Modeling and Simulation (CM&S) Program focuses on regulatory science strategies to achieve the delivery of medical product solutions in a responsible, patient sparing way that relies on computational modeling and simulation as valid scientific evidence to provide increased trust in device performance while limiting the delay in patient access that is commonly associated with elevated certainty.

The vision of the CM&S Program is to aid in the creation and approval of safe and effective medical devices by providing access to:

  • Regulatory-grade computational modeling and simulations
  • Forums for discussing CM&S topics
  • The latest CM&S validation and reporting documents

Current as of January 31, 2023
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