In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis.
Please read the article which is an investigation of the current state of the art regarding the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic: Toward_A_Regulatory_Pathway_for_the_Use_of_in_Silico_Trials_in_the_CE_Marking_of_Medical_Devices
Please visit the project website for more information about the H2020 STriTuVaD project