Compliance, assurance and defence
Three practice areas, one team of clinicians and security specialists. We work as an extension of your product, clinical and governance teams rather than as an external audit function.
Clinical Safety
Specialist support for NHS clinical safety standards, including DCB0129 compliance, Clinical Safety Officer (CSO) services, and clarity around supplier and deployment responsibilities.
DCB0129 Compliance & Consultancy
The AbedGraham Group provides specialist DCB0129 (DCB 0129) consultancy and compliance support for organisations developing, supplying, or maintaining health IT systems used within the NHS. We help you interpret the standard, produce the required clinical safety documentation, and meet your obligations confidently and quickly. Whether you need full end-to-end delivery, an outsourced Clinical Safety Officer (CSO), or support maintaining compliance over time, our consultants work as an extension of your team.
DCB0129 Support & Assurance
The AbedGraham Group provides specialist DCB0129 (DCB 0129) compliance consultancy for organisations supplying health IT systems to the NHS. We help you understand what compliance means in practice, produce the required clinical safety artefacts, and demonstrate proportionate clinical risk management with confidence. Our consultants support organisations at every stage, from an early gap analysis through to ongoing compliance for live NHS deployments. Discuss your product, risk profile, and NHS requirements with a specialist.
Clinical Safety Officer (CSO) Services Provider
Experienced Clinical Safety Officer support for DCB0129 and NHS digital assurance The AbedGraham Group provides Clinical Safety Officer (CSO) services for organisations developing, supplying, or maintaining health IT systems used within the NHS. We can act as your named CSO under DCB0129, supporting proportionate clinical risk management and producing clear, defensible safety documentation. Our CSOs work closely with product, clinical, and governance teams to ensure clinical safety is embedded in delivery - not just bolted on at the end. Discuss your product, deployment, or assurance requirements with an experienced Clinical Safety Officer.
DCB0160 Compliance & Consultancy
Understanding DCB0160 and how it relates to DCB0129 for NHS health IT suppliers DCB0160 is an NHS clinical risk management standard that applies to the deployment and use of health IT systems within healthcare organisations. It sits alongside DCB0129, which applies to system manufacturers and suppliers. While suppliers are generally not responsible for complying with DCB0160, understanding the standard is essential for supporting NHS customers, avoiding confusion, and ensuring smooth deployment.
Cybersecurity
Cybersecurity governance, assurance and operational support for healthcare, life sciences and regulated technology suppliers, aligned to UK and EU requirements.
DSPT Audit & Compliance Readiness Services
The NHS Data Security and Protection Toolkit (DSPT) is a mandatory assurance requirement for IT suppliers and technology providers that access NHS data or connect to NHS systems. For many suppliers, DSPT compliance must be supported by independent third-party assurance, particularly where a DSPT audit is contractually required or where higher levels of assurance are expected by NHS customers.
vCISO for Healthcare & Life Sciences
Cybersecurity leadership is no longer optional in regulated healthcare markets. Whether you are building digital health software, operating clinical networks, manufacturing medical devices, or managing sensitive research data, you are expected to demonstrate mature governance, risk management, and operational cyber resilience.
Incident Response for Healthcare & Life Sciences
When a cyber incident occurs, speed and precision matter. But in healthcare and life sciences, the stakes are even higher: - Patient safety can be impacted - Operational disruption escalates quickly - Regulatory exposure increases with every delay - Executive accountability is now a reality under modern cyber frameworks
Managed SOC & SIEM for Healthcare & Life Sciences
A Managed SOC (Security Operations Centre) with SIEM (Security Information and Event Management) capabilities provides the operational backbone needed to detect, respond and maintain resilience.
Cybersecurity Audit for Healthcare
A cybersecurity audit provides an independent assessment of your organisation's security posture, helping identify strengths, gaps, and areas for improvement. The AbedGraham Group delivers cyber security audits for NHS suppliers, digital health companies, medical device manufacturers, and healthcare technology providers seeking assurance against recognised industry frameworks. The result is a clear, evidence-based view of your current cybersecurity maturity, supported by practical recommendations to strengthen resilience, support procurement requirements, and demonstrate assurance to customers, regulators, investors, and other stakeholders.
ISO 27001 Compliance & Consultancy Services
ISO 27001 is the internationally recognised standard for information security management, helping organisations establish, maintain, and continually improve their approach to managing information security risks. The AbedGraham Group provides end-to-end ISO 27001 consultancy for health-tech, digital health, medical device, and healthcare suppliers, supporting organisations from initial gap analysis through to certification readiness and ongoing compliance. Our specialists help organisations build practical, risk-based Information Security Management Systems (ISMS) that satisfy customer, procurement, regulatory, and stakeholder expectations while strengthening organisational resilience. We guide you through ISMS scoping, risk assessment, ISO 27001 Annex A controls implementation, internal audit activities, and preparation for independent certification audits conducted by accredited certification bodies.
ISO for Cybersecurity
The best way for organisations to meet the UK and EU's cybersecurity regulations is to implement a suite of ISO standards with our expert guidance
AI & Medical Devices
Compliance and assurance support for AI-enabled products and medical devices, covering classification, evidence, risk management and standards aligned to regulatory and market expectations.
AI Medical Device Compliance (UKCA & EU MDR)
AI is rapidly becoming embedded across digital health products, clinical software, and connected medical devices from decision support tools and imaging analysis to remote monitoring, diagnostics, and workflow automation. But as AI capability increases, so do regulatory expectations.
Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) products must meet specific regulatory requirements before they can be placed on the UK market. AbedGraham provides end-to-end regulatory, quality, and compliance support for digital health, health technology, medical device, and AI developers seeking access to the UK healthcare market. Our experts support manufacturers throughout the product lifecycle, including device classification, regulatory strategy, clinical evaluation, quality management systems, UKCA marking preparation, post-market requirements, and UK Responsible Person (UKRP) services for international organisations.
UK & EU Regulations
Find out about the different cybersecurity and safety regulations that are mandatory for businesses operating in the UK & EU and how are services will help you to comply with them