The practice, and who runs it

The through-line is regulated products that actually shipped. At Newel Health he is co-founder and COO of a certified legal manufacturer, where the work runs from quality system and certification strategy through to commercial partnerships with pharma, insurers, and health systems. Before that, as CTO of Healthware Therapeutics — running alongside four years as CTO of Paginemediche — and then as Director of Healthware Factory, he led engineering and product for digital health platforms and designed H.Core, a software framework built under IEC 62304 and ISO 14971 that has since carried three EU MDR Class IIa products through certification.

Alongside those roles he founded and ran two of his own companies — Voodoo and Cyclosee — and served as interim CTO for several funded health-tech startups.

That combination is the point of the advisory. The people giving regulatory advice are frequently not the people who have had to live with it afterwards — through an audit, a notified body queue, or a product that has to keep shipping while the quality system holds. Humanize Health exists to make that experience directly available to founders who need a strategy that survives contact with a reviewer.

Based between Italy and Estonia, advising across the EU. Estonia is not an incidental detail: it runs the most comprehensively digitised health system in the Union, and working inside it is a useful corrective to treating interoperability, identity, and health data access as theoretical problems.