In silico clinical trials are the future of medicine and virtual testing and simulation are the future of medical engineering. Usage of computational platform will provide lower costs and less required time for developing new models of medical devices and drugs. We started to use multiscale modeling and artificial intelligence application of cardiovascular disease which consider a comprehensive list of patient specific features as genetic, biological, pharmacologic, clinical, imaging and cellular aspects. The aim is to avoid adverse effects, drug interactions, preventing sudden cardiac death, shortening time between the drug treatment commencement and the desired result. It will open a new avenue for research and commercial projects to better recognize in silico paradigm inside medical device and drug industry. Medical devices similar as drug in the pharmaceutical industry play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. Regulatory issues impact on the whole cycle of the innovation for medical device. We are in a stage of transition as artificial intelligence (AI) and insilico clinical trials are increasingly being used in healthcare across the world. Regulatory bodies have to understand that software itself could be the software as a medical device (SaMD). In order to avoid the current error in the pre-clinical applications of modeling and AI explainable and approvable AI decisions are necessary for the safe use of modelling and AI in the real patients. Regulation of insilico clinical trials is still at the beginning of development. All major regulatory bodies around the worlds have defined or just starting to define requirements for insilico clinical trials.