Skip to content

Supporting and optimizing the market approval process

The US FDA underpins the rising need for advanced computational modeling and simulation in the medical device market. FEops’ simulation technology advances the field of predictive simulation for structural heart interventions and helps accelerate medical device innovation and regulatory decision-making.

In place of physically testing each size, computational modeling and simulation can predict implant size in a device family expected to perform the worst under simulated in vivo conditions, resulting in lower costs and less time spent at the bench.

Discover more details about the FDA’s stance on the benefits of computational modeling and simulation.

FDA articles:

Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

FEops simulation technology is used to perform accurate stress/strain analyses to determine fatigue safety factors

stress/strain analyses