EU AI Act – Consulting for Medical Software & Health AI Systems

Why Work With Us

• We have extensive experience working at the intersection of AI, medical devices, and regulatory compliance, ensuring your product aligns with both the EU AI Act and the Medical Device Regulation.

• We simplify the complexity of compliance by creating practical and actionable processes for your team.

• Our solutions prioritise efficiency and practicality, minimising disruptions to your development workflow.

• We stay up to date with the latest developments in the EU AI Act, ensuring your compliance strategy is future-proof.

• We focus on transparency, ethical AI practices, and robust risk management to help you meet both regulatory and public expectations.

To whom does the EU AI Act apply?

The EU AI Act applies to providers, developers, and users of AI systems operating in the European Union. It introduces stricter requirements for high-risk AI systems, including:

• AI systems used in medical devices and health software, particularly those impacting diagnosis, treatment, or patient safety.

• AI algorithms supporting decision-making in healthcare, such as diagnostic tools, monitoring systems, or predictive analytics.

• Software incorporating AI that qualifies as a medical device under EU MDR or IVDR regulations.

Our Focus Areas of EU AI Act Compliance

• Risk Management: We identify, assess, and mitigate risks associated with your AI system, integrating these processes with frameworks like ISO 14971 to ensure safety and compliance.
• Data Governance: We establish processes to ensure your datasets are high-quality, unbiased, and representative, meeting EU AI Act requirements for training, validation, and testing.
• Transparency: We create clear documentation for your AI system, detailing its purpose, functionality, and limitations, ensuring compliance with transparency obligations.
• Post-Market Monitoring: We implement mechanisms to monitor your AI system’s performance and safety after deployment, enabling continuous compliance and reliability.
• Conformity Assessment: We prepare your technical documentation and support you through Notified Body assessments and regulatory reviews for successful compliance.
• Integration with Other Regulations: We align your EU AI Act compliance strategy with MDR, IVDR, and GDPR to streamline processes and ensure full regulatory coverage.

How the EU AI Act Integrates with Other Regulations

The EU AI Act works alongside other regulatory frameworks, such as the EU MDR, IVDR, and GDPR. Our team ensures seamless integration of these regulations into your compliance strategy, streamlining processes and avoiding redundancies.