FEA and CFD based Simulation and Design for Medical and Biomedical Applications
FEA & CFD Based Simulation Design Analysis Virtual prototyping MultiObjective Optimization
FEA and CFD based Simulation design and analysis is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process. Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.
FDA submissions require a comprehensive audit trail which includes:
- Records of all simulation data
- Revision management and control
- Correlation with physical test results
- Proven repeatable methods
- Software version tracking
To ensure confidence in the simulation and reliability of the analysis results, medical device manufacturers must ensure that the CAE analyst is using the most current CAD geometry, specify the correct material properties, and apply the appropriate environmental loading conditions. They must also create the proper mesh type and size, record the version of the analysis software, and correlate results with physical test data. These criteria must be preserved and managed for FDA compliance purposes and for the benefit of enhanced enterprise productivity.
As part of our promise to excellency, we have experts with FDA's guidance for Reporting Computational Modeling and Simulation (CM&S) Studies in Medical Device Submissions.
Medical applications are typically subjected to a wide range of complex environmental and biological loading conditions.The variability of these conditions makes the physical testing of all possible scenarios both difficult and time-consuming. By using FEA and CFD multidisciplinary and multiphysics simulation technology, our engineers can study a greater number of real-world design behaviors with higher accuracy.