Developing Software as a Medical Device (SaMD) for Immune-Mediated Inflammatory Diseases requires a robust, compliant technical foundation. This session explores how First Time Right DX (FTR DX) accelerated the launch of their I-Mart platform by building directly on Mia-Care’s specialized infrastructure. Co-founder Andrea Fiumicelli will share how FTR DX innovates the market by unifying physicians, labs, and bioinformaticians into a seamless, SaMD-compliant workflow. We detail the transition from manual biopsy interpretation to an automated system for longitudinal disease tracking and AI-enhanced decision support. Attendees will learn how I-Mart orchestrates the diagnostic lifecycle—from kit scanning to data analysis—on a natively hosted infrastructure. Discover how this partnership allows innovators to focus on clinical excellence while Mia-Care manages the complexities of scale and regulatory compliance.
