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, if you know how to present it.
The Regulatory Reality
Here’s what regulators are looking for:
- Accurate, validated models of real-world behavior
- Sensitivity analysis across physiological ranges
- Well-documented assumptions, boundary conditions, and inputs
- Repeatability of results
- Support for ISO and ASTM standards
COMSOL empowers engineers to simulate:
- Automatic dosing logic under failure scenarios
- MRI heating models in variable patient anatomies
- Fluid mechanics in microfluidic drug delivery
- Electrical fields around wearable biosensors
Each of these models can be exported, documented, and referenced in regulatory submissions to reduce reliance on bench testing or animal studies.
Getting to YES Faster
By including in silico results, teams can:
- Reduce preclinical burdens
- Focus physical testing on edge cases
- Justify design changes without restarting validation
- Shorten time to market—especially in 510(k) or De Novo pathways
It’s not just about speed, it’s about strategy. By using simulation, you’re not just getting to market faster, you’re doing it smarter. You’re ahead of the curve, and it all starts with simulation. Contact Us.