Computer Modelling and Simulation
Medical Device & Human Body Modelling
Verification, Validation & Uncertainty Quantification
In-silico Medicine – Virtual Clinical TrialsContact
Computer Modeling and Simulating (CM&S) has the potential to accelerate the long and challenging development process of medical devices and to move faster to the market, while reducing significantly costs associated with development and V&V activities. International regulatory agencies like EMA or FDA are recognizing the vast opportunities of making CM&S the fourth column in the medical device development process, besides bench-top testing, in-vitro, and in-vivo studies.
4RealSim Life Sciences is a leading service provider in that field and offers a large array of sophisticated multi-physics simulation processes & tools that support all phases of the medical device development process – from virtual feasibility studies via classic device verification and validation analyses to augmenting your human clinical studies with corresponding modelling and simulations – the in-silico trial. We offer in the simulation services for the following physical domains:
4RealSim offers various simulation-, exploration-, and optimization-tools that dramatically improve the understanding of the design space at the beginning of a development phase, while in a later stage yield robust & optimized designs.
4RealSim consultants have experience in a wide range of capabilities. Some of them include
4RealSim is offering the following fully ASTM- & ISO-compliant simulations services.
4RealSim is actively involved via various task forces & research projects (e.g. SimInSitu) to explore and develop computer models and simulation processes with the needed credibility necessary to generate in-silico clinical data for a device certification submission. 4RealSim is furthermore actively involved in defining the necessary regulatory framework to would allow in-silico methods to become a viable tool.
4RealSim offers simulation services, which are in full compliance with state-of-the-art standards and guidance to establish and document the needed credibility for the developed computer models and conducted simulation analyses. This includes generally problem-specific & risk-based model-verification, model-validation, and uncertainty quantification / propagation.
Contact firstname.lastname@example.org to obtain more information on the life sciences & medical devices services.