EU AI Act & ISO 42001 – Cybersecurity and Governance for AI-Driven Medical Devices

The EU AI Act Will Reshape How You Build, Certify and Maintain Software as a Medical Device

The EU Artificial Intelligence Act is the world’s first comprehensive AI regulation — and it will profoundly impact medical device manufacturers, especially those producing Software as a Medical Device (SaMD) or embedding AI/ML models into diagnostics, clinical decision support, and robotic systems.

The Act introduces risk-based classification, with most medical AI falling under the “high-risk” category. This means your AI-enabled device will face:

• Mandatory conformity assessments

• Robust transparency, cybersecurity, and human oversight requirements

• Long-term monitoring and post-market obligations

  
  

At the same time, medical software products remain governed by the Medical Device Regulation (MDR) and, for network-connected technologies, by NIS2. Managing these overlapping regimes demands strategic alignment across clinical, technical, legal, and cybersecurity domains.

Why It Matters to Medical Device Manufacturers

The convergence of AI, cybersecurity, and regulatory governance is no longer theoretical. It’s happening now. From explainability and bias monitoring to data integrity and system resilience, the EU AI Act mandates a new level of operational transparency that few device manufacturers are currently prepared for.

Additionally, with cybersecurity now treated as a core safety concern, the ability to demonstrate secure-by-design development practices, continuous monitoring, and incident response preparedness is vital not only for compliance — but for clinical adoption.

How The AbedGraham Group Can Help

We bring together deep experience in medical device regulation, AI governance, and cybersecurity to help you operationalise compliance and build stakeholder trust.

Our services include:

• EU AI Act compliance roadmapping: risk classification, conformity pathway support, and governance design

• ISO 42001 implementation: enterprise AI management systems tailored for medical device contexts

• Cybersecurity assessments: aligned to ISO 27001, ISO22301, ISO27036 and MDR Annex I Section 17, ensuring AI is protected across its lifecycle

• Product-level and enterprise-level policy frameworks: for ethical AI, human oversight, and traceability

• Cross-regulatory mapping: between MDR, NIS2, AI Act, and ISO standards

What Sets Us Apart

• Cross-disciplinary expertise spanning clinical safety, cybersecurity, and AI governance

• Direct input into national and international health policy

• Practical experience with ISO frameworks in medical device contexts

• Focus on reducing regulatory burden while increasing trust and market readiness

You don’t just need to comply. You need to lead.

Leverage our expertise to turn complex regulatory obligations into a strategic advantage.

Book a discovery call to discuss your AI device roadmap and compliance strategy.

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