# The AbedGraham Group

> Trusted by tech companies for over a decade to navigate UK and EU regulations like DCB0129 and EU NIS2, ensuring cyber resilience and regulatory compliance.

The AbedGraham Group is a UK consultancy founded in 2011 by NHS-trained doctors, working with health tech suppliers, medical device manufacturers and healthcare organisations in the UK and EU. Registered in England and Wales, company number 07787644.

## Clinical Safety

- [DCB0129 Compliance & Consultancy](https://www.abedgraham.com/dcb0129): 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...
- [DCB0129 Support & Assurance](https://www.abedgraham.com/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 Officer (CSO) Services Provider](https://www.abedgraham.com/clinical-safety-officer-cso): 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...
- [DCB0160 Compliance & Consultancy](https://www.abedgraham.com/dcb0160): 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...

## Cybersecurity

- [DSPT Audit & Compliance Readiness Services](https://www.abedgraham.com/dspt): 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...
- [vCISO for Healthcare & Life Sciences](https://www.abedgraham.com/vciso): 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...
- [Incident Response for Healthcare & Life Sciences](https://www.abedgraham.com/incident-response): When a cyber incident occurs, speed and precision matter. But in healthcare and life sciences, the stakes are even higher:
- [Managed SOC & SIEM for Healthcare & Life Sciences](https://www.abedgraham.com/managed-soc-siem): 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](https://www.abedgraham.com/cybersecurity-audit): 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...
- [ISO 27001 Compliance & Consultancy Services](https://www.abedgraham.com/iso-27001): 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...
- [ISO for Cybersecurity](https://www.abedgraham.com/iso-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

- [AI Medical Device Compliance (UKCA & EU MDR)](https://www.abedgraham.com/ai): 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...
- [Software as a Medical Device (SaMD)](https://www.abedgraham.com/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...
- [UK & EU Regulations](https://www.abedgraham.com/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.

## Guidance

- [NHS Digital Health Compliance Guide](https://www.abedgraham.com/post/nhs-digital-health-compliance): Developing a successful digital health product is only part of the journey. (Dr Alexander Graham, 24 July 2026)
- [ISO 13485 is the first step for Medical Device Software Compliance](https://www.abedgraham.com/post/iso-13485-is-the-first-step-for-medical-device-software-compliance): ISO 13485:2016 is the internationally recognised quality management system (QMS) standard for medical device manufacturers, providing the governance framework needed to develop, manufacture, and maintain compliant medica (Dr Alexander Graham, 24 July 2026)
- [ALARP in Digital Health: Understanding Risk Reduction for DCB0129, ISO 14971 and EU MDR](https://www.abedgraham.com/post/alarp-in-digital-health): ALARP stands for As Low As Reasonably Practicable. (Dr Alexander Graham, 13 July 2026)
- [Risk Log vs Hazard Log: What's the Difference?](https://www.abedgraham.com/post/risk-log-vs-hazard-log): Many health technology companies already maintain a risk log or risk register to manage project and business risks. Then they begin preparing for NHS deployment under DCB0129 and discover they also need a Hazard Log. (Dr Alexander Graham, 10 July 2026)
- [What is AMLAS? A Guide to Machine Learning Assurance for Medical Device Manufacturers](https://www.abedgraham.com/post/what-is-amlas-machine-learning-assurance): AMLAS (Assurance of Machine Learning for use in Autonomous Systems) is an open assurance methodology that helps organisations develop structured safety arguments demonstrating that machine learning (ML) components are su (Dr Alexander Graham, 10 July 2026)
- [Clinical Risk Management in Digital Health](https://www.abedgraham.com/post/clinical-risk-management-digital-health): Clinical risk management is the structured process of identifying, assessing, controlling and monitoring risks of patient harm arising from health IT systems. (Dr Alexander Graham, 10 July 2026)
- [Cyber Essentials for NHS Suppliers](https://www.abedgraham.com/post/cyber-essentials-nhs-suppliers): Cyber Essentials has become the baseline cybersecurity certification that many NHS suppliers are expected to achieve as part of procurement, supplier assurance, and wider cybersecurity due diligence activities. (Dr Saif Abed, MD, 2 July 2026)
- [ISO Standards for NHS Healthcare](https://www.abedgraham.com/post/iso-standards-for-nhs-healthcare): ISO standards play an increasingly important role in NHS procurement, assurance, and risk management. (Dr Alexander Graham, 2 July 2026)
- [What is ISO 42001? A Guide for AI Medical Device Manufacturers](https://www.abedgraham.com/post/what-is-iso-42001): Artificial intelligence (AI) is transforming healthcare, from diagnostic imaging to clinical decision support to remote patient monitoring. (Dr Alexander Graham, 2 July 2026)
- [The DSPT Version Guide: Standards-Based to CAF-Aligned](https://www.abedgraham.com/post/dspt-version-guide): The Data Security and Protection Toolkit (DSPT) is NHS England's annual online self-assessment that enables organisations to measure and demonstrate their compliance with the National Data Guardian's data security standa (Dr Saif Abed, MD, 2 July 2026)
- [ISO 27001 Annex A Controls Explained](https://www.abedgraham.com/post/iso-27001-annex-a-controls): ISO 27001 Annex A (sometimes referred to as ISO 27001 Appendix A) is the control reference section of ISO/IEC 27001:2022. (Dr Saif Abed, MD, 29 June 2026)
- [NHS SOC and STRIDE Threat Modelling](https://www.abedgraham.com/post/nhs-soc-stride-threat-modelling): Healthcare organisations face cyber risks at every stage of the technology lifecycle. (Dr Saif Abed, MD, 24 June 2026)
- [NIS2 & Executive Liability – A Critical Priority for Medical Device Manufacturers](https://www.abedgraham.com/post/nis2-executive-liability-a-critical-priority-for-medical-device-manufacturers): The NIS2 Directive, in force across the EU from October 2024, introduces one of the most significant regulatory shifts in cybersecurity governance in over a decade. (Dr Saif Abed, MD, 13 May 2025)
- [Digital Technology Assessment Criteria (DTAC)](https://www.abedgraham.com/post/_dtac): It is essential that any digital health technologies undergo proper assessment. This ensures they meet quality standards and are safe for use, especially within the NHS or social care settings. (Dr Saif Abed, MD, 28 August 2024)

## About

- [About Us](https://www.abedgraham.com/about-us): The AbedGraham Group is a UK-based clinical safety and health cybersecurity consultancy founded in 2011 by two NHS-trained doctors, Dr Saif Abed and Dr Alexander Graham. We support health tech companies, medical device...
- [Dr Alexander Graham](https://www.abedgraham.com/dr-alex-graham): Co-Founder / Chief Operating Officer. Dr Alexander Graham is a UK-trained doctor and one of the country's foremost specialists in the mandatory DCB0129 clinical risk management standard, having led compliance programmes for health IT vendors ranging from...
- [Dr Saif Abed, MD](https://www.abedgraham.com/dr-saif-abed): Founding Partner & Director of Cybersecurity Advisory Services. Dr Saif Abed is a UK-trained physician and one of the world's most widely quoted experts on cyber threats to national healthcare systems. He has served as the lead expert on cybersecurity for the World Health...
- [Contact](https://www.abedgraham.com/contact): Enquiries and discovery calls

## Tools

- [NHS compliance tool](https://www.abedgraham.com/nhs-compliance-tool): Use our free NHS Compliance Tool to check if your products need to fulfil NHS DCB0129, cybersecurity and medical device regulations.

## Optional

- [All services](https://www.abedgraham.com/services)
- [Guidance and press](https://www.abedgraham.com/blog)
- [Privacy policy](https://www.abedgraham.com/privacy-policy)
