Innovators Circle: How to Establish Evidence for an In-Silico SaMD

July 29, 2026 | 1:00-2:00 PM ET | Virtual | MDIC Member Exclusive
Simq OSA is a Software as a Medical Device (SaMD) that diagnoses obstructive sleep apnea by combining patient-specific computational fluid dynamics (CFD) of the upper airway with artificial intelligence. Rather than relying solely on measured physiological signals, the device reconstructs and simulates airflow to derive diagnostic conclusions—positioning it at the frontier of in-silico medicine. This modeling-centric approach delivers clinical value but also raises a central regulatory question: how does one generate and defend evidence for a diagnosis supported by a virtual experiment?

This talk presents the regulatory strategy developed to bring Simq OSA to market in the European Union under MDR, from initial CE certification of version 1.0.0 through the current major change to version 2.0.0. The core of the strategy is an integrated evidence framework that treats computational, physical, and clinical evidence as mutually reinforcing rather than separate. Credibility of the simulation is established through physical bench experiments and model verification and validation, which are then anchored to prospectively and retrospectively collected clinical evidence. This combined body of evidence feeds a structured clinical evaluation demonstrating safety, performance, and clinical benefit consistent with the intended purpose.

We further describe how post-market surveillance and post-market clinical follow-up close the loop—continuously confirming real-world performance of the AI and simulation components and informing lifecycle updates. Attendees will gain a deep insight for qualifying in-silico technologies as diagnostic evidence, and practical lessons on aligning simulation credibility with MDR clinical requirements.

To sign up for the CM&S Innovators Circle, fill out the form below and select the Computational Modeling & Simulation IC. Invites will be sent to confirmed employees of MDIC Member companies. Questions? Contact membership@mdic.org.