October 2025

From Concept to Clearance: How Computational Modeling Accelerates Medical Device Development

Developing a medical device is no walk in the park. It’s more like a hike through regulatory mountains, clinical valleys, and a few budget cliffs. The path from concept to FDA clearance is notoriously complex. However, computational modeling is the relief, the beacon of hope that innovative companies are using to navigate this complexity, reaching […]

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Simulations That Stick: How In Silico Evidence Is Winning Over Regulators

Simulation has always been an engineer’s best friend. Now, it’s becoming a regulatory ally, too. From the FDA to the EMA, agencies are increasingly open to in silico evidence to support design validation, safety assessment, and performance claims for medical devices. If you’re using COMSOL Multiphysics, you’re sitting on a mountain of valuable, submission-ready data,

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