The Clinical Safety,Cybersecurity & AI Expertsfor Health & Life Sciences
The AbedGraham Group is a specialist compliance and assurance firm for healthcare and life sciences.
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A specialist compliance and assurance firm for healthcare and life sciences.
The AbedGraham Group is a boutique regulatory affairs and compliance firm specialising in healthcare and life sciences. Our clients include health tech companies, medical device manufacturers, and healthcare providers that must comply with clinical safety, cybersecurity and AI requirements across the UK and European Union.
Our expertise spans the regulatory standards and laws that underpin market access, including DCB0129, ISO27001, DSPT, UK/EU MDR and evolving frameworks such as the EU AI Act and forthcoming UK Cyber Security and Resilience Bill.
We also provide access to fractional leadership roles that are essential for regulatory compliance such as Clinical Safety Officers (CSOs) for DCB0129 compliance in the NHS and Virtual Chief Information Security Officers.
Find out why we are the UK's most trusted regulatory affairs partner by global technology companies operating in healthcare by booking a meeting with one of our experts today.
- 100+
- Speaking engagements, including 50+ conferences and multiple keynotes
- 50+
- Press citations, BBC to Bloomberg
- 6
- Government & intergovernmental bodies advised
- 2
- WHO reports authored as lead expert, one presented at the UN Security Council
Three practice areas
All servicesClinical Safety · DCB0129
Does DCB0129 apply to your product?
DCB0129 applicability can be confusing. Use our self assessment tool below and book a call with our experts to quickly clear up any uncertainty.
Latest thinking
All insightsALARP in Digital Health: Understanding Risk Reduction for DCB0129, ISO 14971 and EU MDR
ALARP stands for As Low As Reasonably Practicable.
ReadDigital Technology Assessment Criteria (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.
ReadISO 27001 Annex A Controls Explained
ISO 27001 Annex A (sometimes referred to as ISO 27001 Appendix A) is the control reference section of ISO/IEC 27001:2022.
Read…a leading authority on all aspects of cybersecurity in safety critical sectors.
Why teams work with us
- 01Deep specialism in NHS clinical safety and assurance
- 02Proportionate approach aligned to real delivery contexts
- 03Experience supporting startups, established suppliers and multi-national corporations
- 04Clear, defensible documentation that stands up to scrutiny
- 05Consultants who integrate with your team, not slow it down