AI Compliance for Health Tech & Medical Device Manufacturers (UK & Europe)
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.
If your product includes AI features, models, or decision-support functionality, you may be required to demonstrate compliance under:
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EU MDR (Medical Device Regulation)
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UKCA / UK Medical Device Regulations
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ISO-aligned quality and risk management standards
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Cybersecurity and resilience requirements increasingly expected by regulators and customers
At The AbedGraham Group, we provide specialist compliance services for health tech companies and medical device manufacturers building AI-enabled products supporting organisations across the UK and Europe from Class I self-certification through to full compliance for Class IIa and above.
Who This Service Is For
We support:
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Digital health companies building AI-enabled clinical software
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AI-based SaMD (Software as a Medical Device) manufacturers
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Medical device manufacturers adding AI modules or features
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Connected device and remote monitoring product teams
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Health IT and infrastructure vendors operating in regulated healthcare markets
Whether you are early-stage and preparing for Class I self-certification, or scaling into Class IIa/IIb/III requirements, our services are designed to be practical, defensible, and audit-ready.
AI Medical Device Compliance & Market Readiness
AI-enabled products present specific regulatory and compliance challenges across all device classes. We provide practical support to manufacturers to ensure appropriate classification, proportionate evidence, and ongoing compliance aligned with applicable medical device regulations and supporting standards.
Class I AI Products: Self-Certification Support
Many AI-enabled products fall into Class I depending on intended use, claims, and risk profile.
For these products, manufacturers may be able to proceed via self-certification but this still requires structured evidence and compliance discipline.
We support Class I manufacturers with:
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Intended use and claims alignment
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Classification support and justification
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Quality and technical documentation readiness
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Risk management and usability evidence
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Cybersecurity baseline and documentation
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Support preparing for NHS, buyer and procurement scrutiny
This service is ideal for organisations that need to move quickly, but cannot afford compliance mistakes that later block market access.
Class IIa and Above: Full Compliance & Market Readiness
AI products that influence clinical decision-making, diagnostic pathways, or patient management often fall into Class IIa, IIb or higher.
These classes require substantially more evidence, governance and operational readiness including external conformity assessment and robust post-market systems.
We support organisations across the full lifecycle, including:
Core Areas of Support
ISO Standards & Quality Management
We support implementation and alignment across the ISO standards that underpin medical device compliance and regulatory confidence, including:
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Quality management system readiness
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Risk management and design control alignment
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Audit preparation and evidence structuring
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Supplier and outsourced process controls
Cybersecurity & Resilience for AI Medical Devices
Cybersecurity is now inseparable from safety and performance for connected and AI-enabled medical devices.
We provide cybersecurity services aligned to regulated healthcare expectations, including:
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Security governance and risk management
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Secure development and lifecycle controls
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Threat modelling and security assurance
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Incident response readiness and resilience planning
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Evidence packs for technical documentation and audits
Our approach supports both regulatory requirements and the real-world procurement expectations of healthcare customers.
Clinical Evaluation & Clinical Validation
AI products often fail regulatory scrutiny not because the technology is weak, but because the clinical evidence is insufficient, poorly structured, or not aligned to intended use.
We support:
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Clinical evaluation planning
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Evidence strategy and validation approach
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Claims substantiation and performance justification
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Documentation structured for review and audit
Post-Market Surveillance (PMS) & Continuous Compliance
For Class IIa and above, compliance is not a one-time event.
We support:
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PMS system design and documentation
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Real-world performance monitoring strategies
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Feedback and incident handling processes
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Continuous improvement and regulatory readiness
This is especially important for AI products where updates, retraining, or model drift can introduce ongoing risk and regulatory exposure.
Technical Documentation & Audit Readiness
We help manufacturers structure and maintain documentation that is clear, defensible and aligned to expected conformity assessment standards.
This includes support across:
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Technical file readiness
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Risk management file alignment
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Cybersecurity evidence
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Clinical evidence structure
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PMS and vigilance documentation
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Supplier assurance evidence
AI-Specific Compliance Challenges We Help Solve
AI-enabled products introduce additional complexity, including:
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Unclear or shifting intended use and claims
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Dataset provenance, bias and performance evidence
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Model drift and update governance
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Explainability and clinical interpretability
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Human factors and usability risk
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Safety and cybersecurity interdependence
We help you manage these challenges in a way that supports both innovation and regulatory confidence.
Why Choose The AbedGraham Group?
We are specialists in compliance, cybersecurity and standards-based assurance for organisations operating in regulated healthcare markets.
Our work is designed to support:
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Faster market access
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Stronger audit outcomes
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Reduced regulatory risk
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Increased buyer confidence
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Sustainable compliance as products evolve
We bridge the gap between product teams, quality teams, cybersecurity requirements, and clinical evidence — ensuring your AI product can scale safely and credibly.