Our team of experts support companies on all stages of the R&D process, from ideation to the mechanical tests for certifications.
Device Design and Optimization Expertise:
We collaborate seamlessly with your team and medical experts to help design and optimize your devices. By integrating FEA in the early stages, we proactively address design challenges, paving the way for innovative solutions and ensure that the devices meet and exceed the highest standards of performance and safety.
Efficient FDA and CE Certification:
We perform numerical mechanical tests on our custom virtual testbench. Through rigorous methods conducted in accordance with FDA-supported ASME V&V40 standard, we substantially reduce the need for extensive prototypes manufacturing and physical tests, streamlining the path to FDA and CE marks certification.
Realistic Digital Twin Simulations:
We can analyze orthopedic devices in both standard and real-use conditions within our digital twin patients. This approach allows for a comprehensive understanding of device behavior and performance in diverse scenarios. This helps R&D and marketing teams to support clinical claims.
Key features of our services include:
* Precise and Credible Simulation: By employing rigorous numerical mechanical methods in compliance with the FDA-supported ASME V&V40 standard, this simplify the route to FDA and CE marks certification.
* Time and Cost Efficiency: By utilizing simulations to explore critical scenarios, we significantly reduce the need for extensive physical testing. This not only accelerates the preclinical testing phase but also results in substantial cost savings.
* Data-Driven Design: With digital twin simulations reflecting real-use conditions, we provide unparalleled insights into device performance, fostering a deeper understanding of biomechanical interactions.