DIGITAL CLINICAL SAFETY CONSULTING LIMITED

What DIGITAL CLINICAL SAFETY CONSULTING LIMITED does

Digital Clinical Safety Consulting Limited is a UK-based boutique consultancy founded by Dr Yasmin Karsan that provides digital clinical safety and NHS regulatory compliance services to health technology companies. The firm is registered as AnyRx Limited (company number 09358575) with its registered office in Croydon, Surrey, and operates with 1–10 employees. Its core offerings centre on fractional Clinical Safety Officer (CSO) engagements covering DCB0129 and DCB0160 documentation, hazard log development, clinical safety case reports, NHS DTAC compliance, ISO 14971 alignment, and Software/AI as a Medical Device (SaMD/AIaMD) regulatory support, including Clinical AI Coding services performed by qualified clinicians.

The company's revenue model is a hybrid of professional services and small-scale productised offerings. Bespoke fractional CSO consulting is sold via direct sales with a free 15-minute initial consultation and quote-based pricing that is not publicly disclosed. Recurring revenue comes from The CSO Lab, a subscription community at £49 per month or £490 per year that provides access to CSO courses, the DCBee chatbot, and monthly quizzes. One-off revenue is generated through an e-commerce storefront selling DCB0129/DCB0160 Clinical Safety Checklists for £45 each.

The target customer base spans UK digital health startups (Suvera, Written Medicine, Quicksilva, GeneralPractice.AI, Pausetrack, Oncoflow, GP ai), NHS trusts and healthcare providers, health IT vendors, and AI/ML medical device developers, with Viatris serving as the principal enterprise logo. Marketing relies on founder-authored blog content, published case studies, testimonials, speaking engagements, and the owned CSO Lab community channel. There are no external investors, funding rounds, or parent-company ownership disclosed in the source materials.

Name

DIGITAL CLINICAL SAFETY CONSULTING LIMITED

Legal name

AnyRx Limited

Website

https://digitalclinicalsafety.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

1–10 employees

Short description

Digital Clinical Safety Consulting Limited is a UK boutique consultancy providing fractional Clinical Safety Officer services, NHS DTAC/DCB0129/DCB0160 compliance, and SaMD/AIaMD regulatory support to healthtech startups, NHS trusts, and AI medical device developers.

Ownership category

akta.pro rank

Product category

Healthcare Regulatory & Clinical Safety Consulting

NAICS

Other Scientific and Technical Consulting Services (541690)

SIC

Services-Health Services (8000)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industry

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

Keywords

• Clinical safety consulting
• Digital health compliance
• NHS regulatory services
• Clinical risk management
• Medical device regulation

Headquarters

HQ city

Dorchester

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Consulting Services: Bespoke advisory services provided by experienced Clinical Safety Officers. Services include clinical safety assessments, DCB0129/0160 compliance support, hazard log development, clinical safety case creation, digital health product validation, and training. Sold through direct sales engagement with free initial consultation.
2. CSO Lab Membership Subscription: Subscription-based community membership providing access to CSO courses, DCBee chatbot, and monthly quizzes. Monthly plan at £49/month and annual plan at £490/year. Creates recurring revenue from individual professionals and smaller organisations.
3. Digital Products (Checklists): One-time purchase of DCB0129 and DCB0160 Clinical Safety Checklists at £45 per unit. Sold through e-commerce store for self-service procurement by health IT manufacturers and healthcare organisations.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Digital Clinical Safety Consulting Limited provides bespoke fractional Clinical Safety Officer (CSO) services and consultancy supporting NHS Digital clinical safety standards (DCB0129, DCB0160, NHS DTAC) and Software/AI as a Medical Device (SaMD/AIaMD) regulation for health technology companies. Offerings include Clinical AI Coding, hazard log and clinical safety case development, ISO/IEC standards support, and technical file creation. The firm also operates The CSO Lab subscription community (£49/month or £490/year) with an embedded DCBee chatbot, and sells a DCB0129/DCB0160 Clinical Safety Checklist for £45.

Product overview

Digital Clinical Safety Consulting Limited is a consultancy firm offering expert clinical safety and regulatory compliance services for health technology organisations. The company provides a portfolio of advisory services including Clinical AI Coding, NHS DTAC/DCB0129/DCB0160 compliance support, Software/AI as a Medical Device regulatory guidance, and Fractional Clinical Safety Officers. Additionally, the company offers The CSO Lab subscription membership with DCBee chatbot for professional development, and a DCB0129 and DCB0160 Checklist product for self-service compliance tracking. The offering is a services-led consultancy model rather than a unified software platform.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical AI Coding Service providing highly skilled clinicians to accurately code health data, ensuring precision, compliance, and efficiency for health technology companies developing AI/ML medical products.
• NHS DTAC, DCB0129/DCB0160 Compliance Support NHS regulatory compliance service supporting the manufacturing and deployment of Health IT Systems, including DCB0129 and DCB0160 documentation, hazard log development, clinical risk assessments, and clinical safety case reports.
• Software/AI as a Medical Device (SaMD/AIaMD) Regulatory Support Regulatory support covering ISO and IEC standards alignment and the development of technical files for software and AI medical devices, supporting SaMD and AIaMD product certification pathways.
• Clinical Safety and AI Consultancy Bespoke consultancy service covering system design, product and functionality support, and embedding safety into product development to ensure clinically compliant and safe health technology.
• Fractional Clinical Safety Officer (CSO) Part-time, flexible access to experienced Clinical Safety Officers for startups and organisations needing expert oversight without full-time hire commitments, covering DCB0129/0160 documentation, hazard log development, clinical risk assessments, and governance sign-off.
• The CSO Lab Membership
• DCB0129 and DCB0160 Clinical Safety Checklist

Quantifiable outcome

• Provided expert services at an accessible price point, helping GeneralPractice.AI achieve compliance without exceeding their budget
• +1 more outcomes

Named customers8 records

Segments5 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

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• EY UK Health and Life Sciences: Big-4 consultancy with a UK health practice advising on digital health, medical devices and regulatory compliance for NHS and medtech clients — overlaps as a broad incumbent in regulatory health consulting.
• Capgemini Invent Health UK: Global consultancy with a UK health and life sciences practice delivering digital health, regulatory and transformation work for NHS and pharma clients — same general ecosystem, broader portfolio.
• Accenture Health UK: Global consulting giant with a dedicated UK NHS Digital practice delivering large-scale health IT transformation programmes; competes indirectly on NHS digital and clinical safety work as part of much broader service portfolio.
• PwC UK Healthcare: Big-4 consultancy operating a UK healthcare advisory practice covering NHS digital, regulatory and clinical transformation — comparable on broad health regulation and digital deployment work.
• Deloitte Health UK: Big-4 consultancy with a UK health and life sciences practice advising on digital health strategy, regulation and transformation for NHS and life sciences clients — overlaps with the regulatory/compliance corner of Digital Clinical Safety.
• KPMG UK Healthcare: Big-4 consultancy with a dedicated UK healthcare team advising on digital health, medtech and NHS-related regulatory programmes — competes as a broad incumbent in the same client ecosystem.

Direct peers

• Adelphi Group: Pharmaceutical and digital health consultancy with real-world evidence, medical affairs and health technology practices serving pharma, medtech and digital health clients — overlapping target market in regulated health evidence and compliance.
• Avido Health (formerly Apira): UK health technology consultancy offering NHS digital programme delivery and clinical safety advisory, serving similar health-tech and NHS clients with overlapping DCB0129/0160 and DTAC work.
• Gemserv: UK-based data and digital health consultancy advising on NHS standards, clinical risk management and health IT compliance — directly comparable service portfolio to Digital Clinical Safety in the same UK regulatory niche.

Others

• BSI Group (British Standards Institution): UK-based national standards body that develops and certifies ISO/medical device/health IT standards underpinning Digital Clinical Safety's consulting work — adjacent ecosystem participant rather than a direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/digital-clinical-safety

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 DIGITAL CLINICAL SAFETY CONSULTING LIMITED