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Medical devices companies use modelling and simulation in the design phase but it’s now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.
FDA has produced guidelines, and there is also a technical standard to assess the credibility of these models (ASME VV-40-2018).
In Europe it is all more confused by the introduction of the new MDR makes such new approach appealing for many products.
Editor’s note: Image sourced from change.org/p/guido-rasi-foster-adoption-of-in-silico-trials-through-ema-s-strategy-on-regulatory-science-to-2025
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Posted by Marco Viceconti
Asked on December 21, 2019 10:05 pm
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