Finite Element Analysis and Regulatory Approval
We specialize in applying Finite Element Analysis to implantable devices and improving their quality, documentation and value. We know what needs to be done and can help you minimize risk to product development timelines and clinical trials.
Find out how an expert engineering analysis could move you closer to getting regulatory approval.
We can help you identify the best opportunities for leveraging advanced engineering analysis unique to your application. Our experience includes fully coupled multi-physics, Finite Element Analysis (FEA), Computation Fluid Dynamics (CFD), Fluid Structure Interaction (FSI), RF, heat and mass transfer, modal analyses, optimization studies, etc.
- Design review
- Boundary condition studies
- Manufacturing feasibility studies
- Product optimization and sizing
- Stress and fatigue analysis
Learn about custom and automated workflows for leveraging medical imaging analysis on the engineer’s desktop.
Ask about fatigue analysis , devices, design and optimization, test protocols and safety factor methodology. We offer customization including the development of user material subroutines (umats) for example, nitinol, biological and other materials, polymers, blood, tissue, bone, etc.
Learn more about our engineering analysis services for medical devices at any stage in the product development process.
- CE Mark
- HDE = Humanitarian Device Exemption
- 510k = Investigational Device Exemption
- PMA = Pre-Market Approval