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This presentation will introduce the role of computational modeling for medical devices, describes OSEL's ongoing research, and overviews how evidence from computational modeling (i.e., digital evidence) has been used in regulatory submissions by industry to CDRH in recent years. It concludes by discussing the potential future role for computational modeling, in silico medicine and digital evidence in medical devices with the announcement of a new collaboration to advance in silico clinical trials.doi:10.6084/m9.figshare.9107870 fatcat:4axpvydwfnd5fitrfjqnxgixrm