In silico evidence for regulatory approval of medical devices

Together with the AKRA TEAM we invite you to participate to a joint webinar on in silico evidence and discover how the use of In Silico Trials can make safer products, reduce development time, and innovate the R&D process.

Modeling and simulation allow to accelerate the design and development of new medical devices, from improving the efficiency of benchtop pre-clinical testing, to reducing, refining, and replacing in vivo tests on animals and patients during clinical trials, up to augmented post-market monitoring. Already successfully used for decades in many industrial sectors such as aerospace and automotive, this cutting-edge technology is finally about to revolutionize the medical industry, helping to increase the safety and efficacy of new medical devices, while significantly reducing their development cost and time to market.

In the past years regulators have started recognizing [1] and even advocating [2] the use of In Silico Trials to make safer products, reduce development time, and innovate the R&D process. Although the use of computational results to support regulatory approval of new medical devices is relatively new, the first examples of guidelines [3] and standards [4] to cover the reporting and credibility of numerical solutions have been released, with additional guidance documents being under discussion [5]. In particular, a consensus effort involving industry and academia is currently ongoing toward the definition of Good Simulation Practices [6], to reach a consolidated list of industrial practices to easily develop reliable In Silico Trials solutions

InSilicoTrials and the AKRA TEAM are collaborating to support stakeholders in the healthcare industry achieve their objectives in a highly regulated market, by leveraging both technological innovation and regulatory know how to mitigate risks and increase certification success in the EU Market.

InSilicoTrials has built a unique cloud platform where powerful computational models, developed by top scientists at renowned universities, research centers and companies worldwide, are made available to the healthcare industry in an easy-to-use and cost-effective manner, in line with the continuously evolving regulatory guidelines.

AKRA TEAM was established to support medical device, in-vitro diagnostic and combination device innovators, manufacturers, notified bodies and regulators finding practical and reasonable solutions in a highly regulated field addressing both market but also patient expectations. AKRA TEAM is there to ensure that patients receive safe and effective devices in a timely manner and that innovations still have an ability to reach relevant patients.

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