What Santegic does

Santegic is an Irish-registered specialist healthtech consultancy headquartered in Waterford, operating since 2023 with a team of 1–10. It runs two integrated service strands targeting healthcare providers and MedTech companies: Santegic Advisory, led by Clare Harney with prior experience at HIQA, HSE, and the Department of Health, covering EU MDR/AI Act regulatory strategy, ISO 13485 certification, digital health market access, executive-as-a-service, and rapid functional prototyping; and Santegic Cyber, led by Dr. Anita Finnegan (ISO/IEC standards author, SFI Entrepreneurship Award recipient), providing clinical cybersecurity advisory spanning NIS2 readiness, vendor cyber assurance, ISO/IEC compliance, and board cyber governance. The firm complements these advisory strands with two delivered partner products, AuthX (secure authentication across EPRs, PACS, and clinical apps) and Certify Health (patient access and digital intake for Irish hospitals), plus free NIS2 self-assessment tools that act as lead generation.

The technology footprint is primarily human-delivered professional services supported by content assets (the Industry Insights blog) and lightweight self-service web tools (NIS2 Applicability Checker, NIS2 Readiness Scorecard); the partner products add standards-based SSO, HL7/FHIR integration, adaptive MFA, and optional biometric patient verification. Santegic monetises through quote-based consulting engagements and retainer relationships sold directly by its principal advisors, targeting Ireland, the UK, and broader European healthcare and MedTech clients, with an explicit near-term intent to extend into the US market via a Senior Advisor hire.

Name

Santegic

Legal name

Santegic Ltd

Website

https://santegic.com

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

Santegic is an Irish healthtech consultancy providing EU MDR, AI Act, NIS2, and ISO 13485 regulatory advisory alongside clinical cybersecurity services to healthcare providers and MedTech companies across Ireland, the UK, and Europe.

Ownership category

akta.pro rank

Product category

Healthcare Regulatory & Cybersecurity Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416), Other Computer Related Services (541519)

akta.pro primary industry

Governance, Risk & Compliance (GRC) Advisory & Assessments (BPAKAHAH)

akta.pro secondary industry

Security Governance, Risk & Compliance (GRC) Advisory (BPAKADAG)

Keywords

• Healthcare consulting
• Medical device compliance
• Clinical cybersecurity
• EU MDR advisory
• NIS2 readiness

Headquarters

HQ city

Waterford

HQ country

Ireland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Technology or R&D, Infrastructure

Revenue model

1. Healthcare Advisory Services: Professional consulting services covering regulatory strategy, EU MDR/AI Act compliance, ISO 13485 certification, digital health strategy, and executive-as-a-service engagements. Delivered by a team led by Clare Harney with experience across HIQA, HSE, and Department of Health.
2. Cybersecurity Advisory Services: Clinical cybersecurity advisory for healthcare providers and MedTech companies covering cyber risk advisory, NIS2 compliance, ISO/IEC compliance, vendor cyber assurance, and board cyber governance. Delivered by Dr. Anita Finnegan's team.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Santegic is a specialist healthcare consultancy providing regulatory, compliance, and cybersecurity advisory services to healthcare providers and MedTech companies. It operates two service strands: Santegic Advisory (led by Clare Harney) covering EU MDR, EU AI Act, ISO 13485, digital health strategy, and executive-as-a-service engagements; and Santegic Cyber (led by Dr. Anita Finnegan) covering clinical cybersecurity, NIS2 readiness, vendor cyber assurance, and board-level cyber governance. The firm also delivers two partner products, AuthX (secure authentication) and Certify Health (patient access), to Irish healthcare environments.

Product overview

Santegic is a dual-strand healthtech consultancy offering advisory services and cybersecurity solutions. The Santegic Advisory strand (Healthtech Advisory) covers regulatory strategy, EU MDR compliance, EU AI Act alignment, ISO 13485 certification, digital health strategy, executive advisory, and rapid functional prototyping. The Santegic Cyber strand covers vendor cyber assurance, NIS2 readiness, board governance, and cyber retainers for healthcare providers and MedTech companies. Supporting these core services, Santegic offers two partner-delivered products: AuthX (secure authentication with passwordless login, SSO, session roaming, and adaptive MFA) and Certify Health (patient check-in, digital intake, identity verification, and payments for Irish hospitals). Free assessment tools include the NIS2 Applicability Checker and NIS2 Readiness Scorecard.

Differentiator

Problem solved

Functional benefit

Products and services

• Santegic Advisory Healthtech regulatory strategy and advisory services covering EU MDR, EU AI Act, data governance, ISO 13485, and digital health market access. Delivered by a team led by Clare Harney with experience across HIQA, HSE, and the Department of Health. Targeted at MedTech companies, healthcare providers, and digital health innovators.
• Santegic Cyber Clinical cybersecurity advisory for healthcare providers and MedTech companies covering cyber risk, NIS2 compliance, ISO/IEC compliance, and security governance. Delivered by a team led by Dr. Anita Finnegan, ISO/IEC standards author and SFI Entrepreneurship Award recipient.
• Vendor Cyber Assurance Programme Systematic assessment and management of third-party cyber risk for healthcare organisations, evaluating supplier security posture and supply chain resilience.
• Assessment Readiness Programme Preparation programme for MedTech companies and healthcare suppliers facing security assessments, building documented and audit-ready security posture for procurement compliance.
• Board Cyber Governance Programme Executive and board-level cyber security governance framework development, ensuring leadership visibility and accountability for cyber risk at the highest organisational levels.
• Advisory Retainer Ongoing advisory engagement providing continuous regulatory and compliance support for healthtech companies, offering sustained access to specialist expertise.
• Cyber Retainer Ongoing cybersecurity advisory engagement providing continuous access to specialist healthcare cyber expertise for sustained security programme development.
• Regulatory & Compliance Service Strategic guidance on regulatory pathways including EU MDR/SaMD, EU AI Act, data governance, and ISO 13485 certification for digital health companies.
• Digital Health Strategy Advisory on digital health market access, go-to-market strategy, and digital transformation for healthcare organisations and healthtech innovators.
• Executive-as-a-Service Senior executive-level advisory support for healthtech leadership, providing board-level guidance on regulatory, compliance, and strategic decisions.
• Rapid Functional Prototyping Accelerated validation of healthtech product concepts through working prototypes that test clinical workflow fit, integration dependencies, and stakeholder alignment before full development commitment.
• AuthX Secure authentication platform for Irish healthcare unifying sign-in, session management, and strong authentication across EPRs, PACS, and clinical apps. Delivered and supported by Santegic, featuring passwordless login, SSO, session roaming, adaptive access security, and self-service recovery.
• Certify Health Unified patient access platform for Irish hospitals and HSE environments that streamlines pre-visit and arrival processes, digital intake, consent-first identity verification (with optional FaceCheck biometric authentication), patient portal, smart communications, and PSD2/SCA-compliant payments. Delivered by Santegic partner Certify Health.

Quantifiable outcome

• 60+ organisations supported across Ireland and UK

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

AI capability4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Certify HealthcoreGTM or Marketing PartnerCertify Health is a Santegic partner offering patient access and clinic management solutions. Santegic supports Certify Health's market positioning and go-to-market strategy within Irish healthcare markets. Certify Health provides patient check-in, digital intake, and payment solutions for HSE hospitals and independent providers.
• AuthXcoreGTM or Marketing PartnerAuthX is a Santegic partner providing secure authentication solutions for Irish healthcare. AuthX unifies sign-in, session management, and strong authentication across EPRs, PACS and clinical apps. Santegic delivers and supports AuthX product implementation in healthcare environments.
• South East Technological University (SETU)minorStrategic or Co-development PartnerSantegic maintains an office at the SETU Xcelerate Centre, West Campus in Waterford, indicating a collaborative relationship with the university for innovation and technology development support.
• Royal College of Surgeons in Ireland (RCSI)minorStrategic or Co-development PartnerClare Harney lectures at RCSI on Digital Health Transformation and Santegic supports curriculum development and the Digital Health Leaders Programme.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• BSI Group: BSI is a global standards, certification, and compliance body active in ISO 13485, medical device cybersecurity, and healthcare standards — directly comparable to Santegic's ISO/IEC and NIS2 advisory services.
• ICON plc: ICON is a global CRO and healthcare consulting firm offering regulatory, clinical, and commercialization services to MedTech and biopharma, comparable as a much larger incumbent serving overlapping healthcare customer segments.
• Costello Medical: Costello Medical is a healthcare-focused consultancy providing regulatory, evidence, and market access services, comparable to Santegic's healthtech advisory and strategy offerings though at significantly larger scale.
• TÜV SÜD: TÜV SÜD offers medical device testing, certification, and cybersecurity assurance services, overlapping with Santegic's MDR/ISO 13485 advisory and medical device cybersecurity work as a much larger incumbent.
• Deloitte (Healthcare & Life Sciences): Deloitte's healthcare practice offers regulatory, cybersecurity, and digital health strategy advisory to providers, payers, and MedTech clients, providing large-incumbent competition for Santegic's enterprise engagements.
• KPMG (Healthcare Advisory): KPMG's healthcare advisory practice provides regulatory, digital health, and cyber risk advisory to providers and MedTech clients, competing with Santegic as a much larger, broader-scope incumbent.

Emerging players

• Claroty: Claroty (which acquired Medigate) secures connected medical devices and clinical environments; relevant comparability to Santegic Cyber's clinical cybersecurity and vendor assurance practice for healthcare providers.

Direct peers

• NAMSA: NAMSA provides MedTech regulatory, quality, and testing services including EU MDR/ISO 13485 and clinical strategy consulting, serving the same medical-device manufacturer buyer that Santegic targets.
• Cynerio: Cynerio is a healthcare-specific cybersecurity company focused on medical device and clinical environment security, directly overlapping with Santegic Cyber's clinical cybersecurity and NIS2 readiness offerings.
• RQM+: RQM+ is a MedTech-focused regulatory and quality consulting firm offering ISO 13485, EU MDR, SaMD, and clinical cybersecurity support, directly overlapping with Santegic Advisory and Santegic Cyber service lines.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/santegic

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Santegic