Hardian Health

What Hardian Health does

Hardian Health (legal entity: Hardian Limited) is a London-headquartered multidisciplinary consultancy that helps health technology developers take software and AI medical devices (SaMD and AIaMD) from idea through to market launch. The firm operates five core service pillars: Regulatory Affairs (EU MDR, FDA, UKCA authorisations, ISO 13485/IEC 62304 QMS, GDPR/HIPAA, NHS DTAC/DCB, ISO 27001), Clinical Evaluation (systematic literature reviews, CER writing, PMCF), Health Economics (early economic modelling, budget impact modelling, cost-effectiveness analysis for NICE/payer submissions), Market Access (value proposition, reimbursement, pricing, M&A and due diligence), and Intellectual Property (freedom-to-operate, patent strategy, trademarking). Its team is clinician-led and includes practising doctors, qualified regulatory auditors, LSE-trained health economists, a 'iam 300'-recognised patent attorney, and a former NHSX Head of Digital Investment Strategy advising on NHS market access.

The company does not develop proprietary software products; its technology stack consists of free, lead-generating assets — an automated ISO/TS 82304-2 health-app self-assessment tool, a 12-hour free SaMD training course delivered in partnership with Health Data Research UK (HDRUK), and a Devices Database — used to attract and qualify healthtech clients before converting them into paid consulting engagements. The firm is ISO 9001 and ISO 27001 certified, is a member of BSI and TOPRA, and reports having supported more than 100 companies on their regulatory journeys, spanning startups, SMEs, and enterprise customers across global markets.

Revenue is generated through project-based professional services engagements with custom, non-publicly-disclosed pricing, supplemented by a freemium model for training and assessment tools (with paid CPD certification through HDRUK). Go-to-market is sales-led and content-driven: organic SEO, a monthly newsletter, an invite-only annual Hardian Health Tech Summit, and direct consulting engagement via face-to-face workshops form the core distribution channels, targeting healthtech developers from pre-seed idea stage through commercial launch.

Name

Hardian Health

Legal name

Hardian Limited

Website

https://hardianhealth.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Hardian Health is a London-based, clinician-led consultancy that provides regulatory, clinical, health economics, market access, and IP services to help healthtech developers bring software and AI medical devices to market, having supported over 100 companies globally.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory & Commercialization Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417)

SIC

Services-Health Services (8000), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

akta.pro secondary industries

DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms (HLACANAM), DTx/SaMD Deployment, Integration & Reimbursement Enablement (HLACANAO)

Keywords

• SaMD regulatory consulting
• Medical device compliance
• Clinical evaluation services
• Health economics modelling
• Healthtech market access

Headquarters

HQ city

Haywards Heath

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Professional consulting services for EU MDR and FDA authorizations for AI and software medical devices. Includes Quality Management Systems, ISO 13485 and IEC 62304 compliance, GDPR and HIPAA compliance, NHS DTAC and DCB documentation, cyber security, and ISO 27001 services. Revenue generated through project-based consulting engagements.
2. Clinical Evaluation Services: Clinical research design, systematic literature review writing, CER writing, PMCF and medical support for regulatory clearance.
3. Market Access Consulting: Value proposition development, competitor landscaping, reimbursement routes, launch strategy, market sizing, stakeholder mapping, pricing, M&A and due diligence services.
4. Intellectual Property Services: Freedom to operate analysis, IP search, IP strategy, trademarking, global patenting, and infringement protection.
5. Health Economics Modelling: Early economic modelling, budget impact modelling, and cost effectiveness analysis for SaMD and AIaMD products.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Hardian Health is a consultancy that helps health tech developers bring software and AI medical devices (SaMD/AIaMD) to market. Its core offerings span five service pillars: Regulatory Affairs (EU MDR, FDA, UKCA, ISO 13485, IEC 62304, ISO 27001, GDPR/HIPAA), Clinical Evaluation (CER writing, literature reviews, PMCF), Health Economics Modelling (NICE submissions, cost-effectiveness analysis), Market Access (reimbursement, launch strategy), and Intellectual Property (FTO, patenting, trademarking). The firm supplements consulting with free educational tools and training resources.

Product overview

Hardian Health is a consultancy company that provides a multidisciplinary suite of services to help health tech developers commercialize software and AI medical devices. The offering consists of five core consulting service pillars: Regulatory Affairs Services (covering EU MDR, FDA, UKCA approvals, ISO 13485, IEC 62304 compliance), Clinical Evaluation Services (including systematic literature reviews, CER writing, PMCF), Health Economics Modelling Services (early economic modelling, budget impact models, cost-effectiveness analysis), Market Access Services (value proposition, competitive analysis, reimbursement strategy), and Intellectual Property Services (freedom to operate, patenting, trademarking). Alongside these core services, Hardian offers a free ISO/TS 82304-2 self-assessment tool and a free SaMD training course in partnership with HDRUK. The company is clinician-founded and helps over 100 companies achieve regulatory approval for their software medical devices.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Services EU MDR and FDA authorizations for AI and software medical devices, including Quality Management Systems, ISO 13485 and IEC 62304 compliance, GDPR and HIPAA compliance, NHS DTAC and DCB documentation, cyber security, and ISO 27001 support. Offered to health tech developers from idea stage through to commercial launch.
• Clinical Evaluation Services Clinical research design, evaluation of AI and software medical devices, systematic literature review writing, Clinical Evaluation Report (CER) writing, Post-Market Clinical Follow-up (PMCF), and medical support for regulatory clearance.
• Market Access Services Value proposition development, competitor landscaping, reimbursement routes, launch strategy, market sizing, stakeholder mapping, pricing, M&A, and due diligence for AI and SaMD products.
• Intellectual Property Services Freedom to operate analysis, IP search, IP strategy, trademarking, global patenting, and infringement protection for software and AI medical devices.
• Health Economics Modelling Services Early economic modelling, budget impact modelling (BIM), and cost effectiveness analysis (CEA) for SaMD and AIaMD products, including value proposition development and support for NICE and payer submissions.
• ISO/TS 82304-2 Self-Assessment Tool Free self-assessment questionnaire covering all aspects of ISO/TS 82304-2 for health apps quality rating, providing scores, quality ratings, and actionable recommendations with a detailed PDF report. Used by healthtech developers and health app developers to assess quality.
• Free SaMD Training Course Free online bite-size course with 12 hours of content covering the software as a medical device (SaMD) landscape, delivered in partnership with HDRUK. Includes 6 video modules and 4 in-depth webinars. CPD certification available for £40 through HDRUK.

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• HDRUK (Health Data Research UK)coreGTM or Marketing PartnerHardian Health partnered with HDRUK to deliver a free online Software as a Medical Device (SaMD) training course. The course consists of 12 hours of content including 6 video modules and 4 in-depth webinars covering regulatory strategy, clinical evaluation, health economics, and intellectual property for medical devices. HDRUK is the UK's national institute for health data science. CPD certification is available for £40 through HDRUK.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• NAMSA: NAMSA is one of the largest medical device-focused CROs globally with a SaMD/digital health practice. It is comparable to Hardian Health as an incumbent offering regulatory, clinical, and market access services for medical device developers, though it serves a much broader medtech base with significantly larger scale.
• Veranex: Veranex is a medtech commercialization consultancy spanning regulatory, clinical, design, and market access services. It is comparable to Hardian Health's full-journey regulatory-to-market-access proposition for SaMD and AI medical device manufacturers, but at considerably greater scale and breadth.
• Lumanity: Lumanity is a global life sciences consulting firm with strong HEOR, market access, and commercialization practices serving pharma and medtech. It is comparable to Hardian Health's health economics and market access consulting pillar for SaMD/AIaMD, but at materially greater scale and breadth.
• ICON plc: ICON is a top-3 global CRO with a dedicated medical device and digital health practice. It overlaps with Hardian Health on clinical evaluation, regulatory, and HEOR support for SaMD developers, though as one part of a much larger services portfolio.

Direct peers

• RQM+: RQM+ is a regulatory and quality consulting firm specializing in medical devices, including SaMD. It directly competes with Hardian Health across ISO 13485 QMS, EU MDR/FDA submission support, and clinical evaluation services for digital health and AI medical device developers.
• ClariMed: ClariMed is a specialty consultancy focused on digital health, SaMD, and AI medical device regulatory and human factors strategy. It mirrors Hardian Health's tight niche focus on SaMD/AIaMD developers and similar service pillars (regulatory, clinical evaluation, HEOR input).
• Medidee: Medidee is a Switzerland-based medical device regulatory and clinical consultancy with strong SaMD and MDR expertise. It is comparable to Hardian Health in serving software medical device developers navigating EU MDR, ISO 13485, and clinical evaluation requirements.
• Medical Device Consultants Inc. (MDCI): MDCI is a US-based CRO and regulatory consultancy for medical devices, including SaMD submissions and clinical evaluation reports. Comparable to Hardian Health in core service pillars—regulatory strategy, clinical evidence, and quality systems for software-driven medical devices.
• Qserve Group: Qserve is a global medical device regulatory, quality, and clinical consultancy. It is a direct peer to Hardian Health across SaMD/AIaMD regulatory support, notified body readiness, and clinical evidence services for European and US market access.

Emerging players

• Greenlight Guru: Greenlight Guru provides QMS and regulatory workflow software purpose-built for medical device companies. It is an adjacent/emerging player relative to Hardian Health's consulting services—serving the same SaMD and medical device developer base but via software rather than consulting engagements.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/hardian-health
• Xx.com/HardianHealth

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 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 Hardian Health