Our Expertise: Healthcare Software, Clinical Knowledge, and AI-Driven Study Design

Mautilus brings together the multidisciplinary expertise required to develop, validate, and bring a digital health solution to market. Our software development follows standardized procedures aligned with ISO 13485, the quality management system standard for medical devices, ensuring that EMCare is built and maintained under a rigorous, auditable framework appropriate for a regulated Software as a Medical Device (SaMD) — from early development through eventual CE marking.

This technical foundation is grounded in direct clinical expertise: our team includes a neurologist specialized in Multiple Sclerosis working within a national reference center (CSUR) MS unit, ensuring that product design, clinical endpoints, and validation strategies are shaped by real-world clinical practice and patient needs rather than developed in isolation from care.

We also bring proven experience in clinical studies, from protocol design through multicenter coordination — including observational and product-focused clinical research under applicable medical device regulation (MDR), biomarker sub-studies, and collaboration with academic and hospital partners across multiple sites. This is complemented by hands-on experience developing and validating AI models for clinical prediction, including deep learning approaches trained and tested on real patient cohorts, giving us the full-stack capability to move from clinical hypothesis to validated, regulator-ready digital biomarker.