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) consulting and compliance support for manufacturing organisations that are developing and supplying health IT systems for use within the NHS. We can help you navigate the standard, produce the required clinical safety documentation for your products and meet your obligations quickly. Whether you need full end-to-end delivery to manage DCB0129, an outsourced Clinical Safety Officer (CSO), or support maintaining compliance, 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
For NHS suppliers providing services that access NHS data or connect to NHS systems it’s mandatory to complete the NHS Data Security and Protection Toolkit (DSPT) on an annual basis. For suppliers with equal to or more than 50 employees and £10m in global annual revenue the DSPT submission must include an independent third-party audit. Even for smaller suppliers a submission audit is increasingly considered desirable as a part of NHS procurement requirements.
vCISO for Healthcare & Life Sciences
Cybersecurity leadership is now a prerequisite for successfully navigating cybersecurity regulations and standards across the UK and Europe. Whether you are developing digital health platforms, manufacturing medical devices, or deploying frontier AI capabilities, you must demonstrate cyber-maturity 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 is an excellent way to rapidly assess your organisation's preparedness and resilience to data breaches and disruptive cyber-attacks. We provide Cybersecurity audits based on recognised international standards for digital health companies, medical device manufacturers, and AI developers operating in UK and European healthcare. The results of our audits generate a gap analysis and benchmark that a cohesive cybersecurity strategy can be built around. This reduces executive liability, enhances risk management and solidifies trust with customers.
ISO 27001 Compliance & Consultancy Services
ISO 27001 is the internationally recognised standard for developing an Information Security Management System (ISMS) which is a dynamic set of policies, procedures and evidence logs that typically address both physical security and cybersecurity requirements for a business. We provide tailored ISO 27001 consultancy services for digital health companies, medical device manufacturers, IT suppliers to healthcare systems and AI companies. This includes certification preparation support, documentation development, gap analysis projects, post-market surveillance and internal audit spot-checks. Our experts are uniquely placed to develop ISMSs that are optimised for the complexities of the healthcare and life sciences sectors through extensive experience across both clinical safety and cybersecurity.
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 becoming integrated across digital health solutions, clinical software, and medical devices ranging from decision support tools and imaging analytics through to remote monitoring, diagnostics, and even workflow automation. But as with greater AI adoption there are increasing risks which are leading to enhanced 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