Medical devices must meet regulatory requirements and standards during the certification process for commercial use and product distribution. This process is more complex when trans-disciplinary teams are involved through the entire product lifecycle.
1D-simulation tools provide an efficient multi-physics analysis platform to evaluate behavior of different aspects of the design against requirements. This platform helps engineers to develop a virtual twin of the final product. This allows designers and analysts to evaluate the design, before any physical prototype is developed.
We explain a method based on Model Based Systems Engineering approach that aligns design, engineering, and manufacturing team to create robust and efficient products. This method allows evaluating and validating the design and product from requirements to manufacturing and services.
Simulation models not only help to generate a virtual twin of the product, also can be helpful through service, troubleshooting and calibration of the equipment. Integration of the MBSE method with change and revision management throughout a project lifecycle helps managers and designers to trace through all aspects of the design during the lifecycle of the product development.