AI Compliance Services
As AI becomes embedded across healthcare, clinical research, and life sciences, organisations face complex compliance obligations under multiple overlapping frameworks. iliomad Health Data provides comprehensive AI Compliance Services ensuring full conformity with the EU AI Act, MDR/IVDR, and related ethical and technical standards.
AI Compliance Framework Components
We deliver complete operational compliance frameworks helping you classify AI systems, manage risks systematically, establish robust governance, and achieve audit-ready compliance with EU AI Act, MDR/IVDR, and related standards.
AI Act compliance begins with the accurate classification of AI systems, which determines their applicability, risk tier, and the scope of resulting compliance obligations and must be properly documented and justified. We guide you through the classification of your AI systems under the EU AI Act, clarify the requirements that apply to them, and, beyond classification, help you embed AI literacy across your organisation so that all relevant stakeholders are equipped to responsibly develop, deploy, and use AI systems.
High-risk AI systems require quality management systems ensuring consistent compliance—including risk management, documentation control, and continuous improvement processes. AI-QMS may integrate with existing ISO 13485 or 27001 systems.
AI systems must meet ethical requirements including transparency, fairness, accountability, and human oversight. Ethical compliance requires both technical measures and organisational processes ensuring responsible AI operation.
The EU AI Act requires comprehensive technical documentation covering system design, development methodology, data governance, testing, and risk management. Documentation must be maintained current and available for regulatory review. Technical documentation requirements are extensive and detailed, covering system descriptions, development processes, data governance, risk management, performance testing, and more.
A We support you through the preparation and execution of Fundamental Rights Impact Assessments under the EU AI Act, supporting the identification, evaluation, and mitigation of risks to fundamental rights and ensuring these considerations are integrated into your AI governance and risk management frameworks.
We help you implement a lifecycle-wide AI risk management system in line with the EU AI Act, covering risk identification, evaluation, mitigation, testing, and post-market monitoring. We define risk acceptance criteria, scoring methodologies, and governance structures, and integrate AI Act requirements into existing risk management frameworks where possible to ensure continuous compliance and accountable AI deployment.
How iliomad Health Data Can Help You
We deliver complete operational compliance frameworks integrating seamlessly with your existing quality systems helping you classify AI models accurately, manage risks systematically throughout theAI lifecycle, establish governance structures with clear accountability, and build documentation that withstands regulatory scrutiny.
FAQs
Our frequently questions
An AI Compliance Framework is the operational infrastructure that ensures your AI systems meet EU AI Act, MDR/IVDR, GDPR, and related regulatory requirements through systematic classification, risk management, governance structures, and ongoing monitoring. Organizations developing or deploying AI in healthcare must demonstrate audit-ready compliance a robust framework transforms regulatory obligations into repeatable, defensible processes that satisfy authorities, notified bodies, and investors.
Our comprehensive framework includes classification and risk assessment (determining your AI system's regulatory category), AI quality management systems (QMS integration with ISO 13485 and MDR/IVDR), ethical compliance and oversight structures, technical documentation packages, fundamental rights impact assessments, and post-market monitoring systems. Each component is tailored to your AI system's risk level, intended use, and regulatory pathway while maintaining consistency with existing quality and compliance infrastructure.
AI-enabled medical devices must simultaneously comply with EU AI Act requirements and MDR/IVDR obligations, creating overlapping documentation, risk management, and post-market surveillance requirements. We design integrated compliance frameworks that harmonize AI Act conformity assessment with MDR/IVDR technical files, align AI risk management with ISO 14971 medical device risk processes, and coordinate notified body submissions to avoid duplication while meeting both regulatory regimes efficiently.
Implementation timeline depends on AI system complexity, regulatory classification, and existing quality management maturity, typically ranging from 8-16 weeks for initial framework establishment. High-risk medical AI systems require more comprehensive documentation and validation, while limited-risk systems can achieve compliance more rapidly we prioritize regulatory blockers first (classification, risk assessment, essential documentation) while building comprehensive governance systematically.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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