Santegic helps healthtech innovators and health systems navigate EU regulation, prove quality and cybersecurity, and reach the market — combining specialist advisors with the Navisan platform. Ireland, UK & Europe.
MDR & IVDR pathways, ISO 13485 and 27001 certification, EU AI Act and EHDS readiness — with NIS2 cyber assurance and board governance built into the same engagement, not bolted on.
Explore Regulatory & Certification →Go-to-market design and market-entry strategy across Ireland, the UK, the EU and the US — tendering, contract negotiation, and reimbursement strategy that gets you paid, not just launched.
Explore Market Access & GTM →Innovation-framework and process design, feasibility studies, and transformation support for health providers and public bodies — turning ambitious ideas into adopted, funded reality.
Explore Strategy & Innovation →Every client-facing output — a regulatory strategy, a certification pathway, a go-to-market plan — is reviewed by a named, accountable expert before it reaches you.
Navisan handles the volume and the repeatable groundwork. Our advisors handle the judgment calls. You always know who's accountable for what you're looking at.
The withdrawal of OpenEvidence, one of the most well-funded AI clinical decision support platforms in the US, from EU and UK markets is a significant signal for every health AI company with European ambitions. The reason given was direct: the complexity of...
Read More →If you're building Software as a Medical Device and you've started looking seriously at ISO 13485 certification, you've probably already discovered something uncomfortable: the standard wasn't written with software in mind...
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