🧪 Simulation Studies for Digital Health — The SIROS Framework
An overview of Imperial’s SIROS framework showing how simulation supports regulatory evidence for Software as a Medical Device (SaMD).
Published on
October 6, 2025
Key takeaways:
The SIROS framework, developed by Imperial’s Institute of Global Health Innovation with Roche Information Solutions, defines standards for using simulation in SaMD evaluation.
Clinical simulation offers a safe, controlled way to test digital health technologies before clinical deployment, helping meet regulatory expectations.
The framework guides regulators, innovators, and developers on assessing safety, performance, and usability through structured simulation studies.
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