Regulatory strategy and market access advisory for the organisations building and running digital health across Ireland, the UK, and Europe.
CIO of the Year 2023 · Fellow and Board Member, Irish Computer Society and HISI
Former Experience: Digital Health Startups, HIQA, HSE & Dept of Health.
RCSI Adjunct Faculty, TU Dublin External Examiner
MSc Health Informatics | MDR/IVDR Certified
Healthtech regulation is complex, fast-moving and unforgiving. The Santegic advisory team has worked inside health systems and alongside the innovators trying to navigate them giving us a direct understanding of what regulators expect, what procurement teams require, and what it actually takes to get a product to market.
Our advisors bring direct experience from the Department of Health, HIQA, and the HSE. That means our clients get insight into how Irish and European health systems actually operate not how they appear on paper.
With postgraduate teaching roles at RCSI and MDR/IVDR certification sitting alongside decades of hands-on advisory work, we help you build compliance into your product from the start, not bolt it on when it's too late.
From initial regulatory strategy through to market access and ongoing compliance, we work with you at every stage whether you're pre-product or scaling across multiple markets
Practical expertise across every stage ofthe healthtech journey from first regulatory question to market and beyond.
Mock audits and ISO 13485 preparation for software medical device companies approaching certification so nothing about the real thing comes as a surprise.
From RCSI postgraduate programmes to bespoke team training, we build the internal capability your organisation needs to lead and sustain digital transformation. Programmes span EHDS, Quality & Safety, Digital Health, Leadership, Innovation, and Strategy.
MDR/SaMD pathways, EU AI Act readiness, GDPR, EHDS, and IVDR mapped to your product, your market, and your timeline. Not a generic checklist. A strategy built for your situation.
Learn MoreGo-to-market design, market access planning, and Ireland / UK / EU entry strategy for healthtech companies at any stage, from early validation to cross-market scaling.
Learn MoreFractional CXO, DPO-as-a-Service, and specialist advisory resource on a flexible retained basis. Senior expertise without the overhead of a full-time hire.
Learn MoreMDR/SaMD pathways, EU AI Act readiness, GDPR, EHDS, IVDR mapped to your product and market entry strategy.
High-risk AI classification for health applications, conformity assessment requirements, QMS integration, and CE marking under the AI Act.
Data governance frameworks, DPO support, and European Health Data Space readiness for digital health companies.
Quality management systems for medical device software - gap analysis, implementation support, and internal audit preparation and execution.
Monthly regulation monitoring • compliance call access • quarterly market access review • priority response time.
Limited places available at any one time.
The organisations we work with rarely face compliance challenges without cybersecurity questions alongside them.
That's why we built Santegic Cyber. Explore Santegic Cyber.
