The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

MDCG 2025-4  Medical Device Software Apps on Online Platforms

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In this audio overview, we delve into the transformative role of Computational Modeling and Simulation (CM&S) in medical device development and beyond, exploring how these advanced virtual tools are reshaping regulatory pathways and accelerating innovation.
You'll learn how CM&S, encompassing various physics-based simulations like Finite Element Analysis (FEA) for structural mechanics and Computational Fluid Dynamics (CFD) for fluid flow, has become a pivotal tool throughout the entire product life cycle of medical devices

A major focus of our overview is the FDA's progressive strategy and guidance on computational modeling. We discuss how the FDA actively promotes and recognizes CM&S evidence for device approval and clearance, aligning closely with the ASME V&V 40-2018 standard. This framework provides a structured, risk-informed credibility assessment framework, defining how simulations should be verified and validated to ensure trust in their predictive capability

Verification and Validation Activities for Computational Models with ASME 40-2018

Miloš Cigoj

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