Building trust in healthcare AI.

Sanaitio helps medtech companies develop, validate, and deploy AI-based medical devices that earn clinical adoption and regulatory approval.

Most AI medical devices get cleared but never get used. Over 950 are FDA-cleared, yet fewer than 1% of studies report real patient outcomes, and 95% rely on regulatory equivalence rather than new clinical evidence. The MDR and AI Act now demand more: clinical impact, transparency, post-market monitoring. By August 2027, full AI Act compliance is required. Devices built on algorithmic performance alone cannot clear that bar.

We close the gap between approval and adoption through Trust by Design, our framework adapted from Quality by Design, the approach that transformed pharmaceutical development. Trust is built in by design, not tested in at the end. We work across the total product lifecycle, from product definition to post-market monitoring.

At the core of our work are causal and Bayesian methods. Our team brings together statisticians, AI engineers, regulatory scientists, and QA experts, focused on the variables that decide whether a device performs, generalises, and earns approval: development variables, clinical endpoints, sources of bias, sample design, uncertainty. Causal graphs make assumptions explicit. Bayesian networks turn them into quantitative tools for designing data collection, validation protocols, and clinical trials under uncertainty.

We engage in four ways: upstream development strategy, clinical validation, regulatory navigation (AI Act, MDR/IVDR, GDPR), and deployment and monitoring.

Three decades of qualifying drugs and processes for the most heavily regulated industry there is. The same rigor, now applied to AI. ISO 9001 principles, sovereign European IT stack. Compliance is built into how we work.

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