We were building a high-risk AI system for clinical decision support and had no idea how to navigate the Act's obligations. The gap analysis and compliance roadmap gave us exactly what we needed to proceed with confidence.
We help you understand the scope, risk-based approach (unacceptable, high, limited, minimal risk), and specific obligations imposed by the EU AI Act on your organization as a provider, importer, distributor, or user of AI systems operating within the EU market.
Stop guessing whether the EU AI Act applies to your organization. A precise scope assessment identifies your regulatory obligations as a provider, deployer, importer, or distributor—saving you from unnecessary compliance costs while ensuring you don't miss critical requirements that could result in fines up to €35 million or 7% of global turnover.
Classification is the gateway decision. Get it wrong and you face either wasted resources on unnecessary compliance or devastating regulatory penalties for missed obligations. Our structured approach analyzes your AI systems against Article 6 and Annex III criteria, ensuring defensible classification decisions that withstand regulatory scrutiny.
The EU AI Act imposes up to 14 distinct obligation categories on high-risk AI systems. Understanding which apply to your specific situation—and how they interact with existing regulations like GDPR, MDR, or sectoral laws—is essential for building an efficient compliance program that doesn't duplicate effort or miss critical requirements.
Our readiness assessment involves inventorying your AI systems, classifying their risk levels according to Annex III and Commission guidance, and performing a detailed gap analysis against the Act's stringent requirements for high-risk systems.
You can't manage what you don't measure. A comprehensive AI system inventory captures not just models, but entire workflows including decision points, human oversight mechanisms, and data flows. This becomes your foundation for all compliance activities and demonstrates due diligence to regulators.
Knowing where you stand today versus where you need to be is critical for resource planning. Our gap analysis identifies not just what's missing, but the severity of each gap and its interdependencies—allowing you to prioritize efforts that deliver maximum compliance impact with minimum disruption.
Article 11 requires extensive technical documentation that cannot be assembled retrospectively. Our review identifies what documentation already exists, what needs to be created, and how to structure your documentation pipeline to support ongoing compliance as systems evolve—preventing last-minute scrambles before conformity assessments.
Based on the gap analysis, we collaborate with you to develop a pragmatic and prioritized implementation roadmap. This outlines necessary technical adjustments, process changes (QMS), documentation efforts, and conformity assessment strategies to achieve compliance efficiently.
Compliance deadlines are approaching fast. A prioritized action plan ensures your limited resources are directed at the highest-impact activities first—those that take longest to implement, have the most significant compliance impact, or create foundation for subsequent requirements. This prevents costly last-minute rushes and ensures steady progress.
The AI Act requires specific technical measures for high-risk systems—risk management systems, data governance, transparency, human oversight, and cybersecurity. We design practical, implementable solutions that meet regulatory requirements while fitting your technical architecture and business constraints.
High-risk AI systems require CE marking before market placement. The conformity assessment route depends on your system type and role—internal production control for most systems, but third-party assessment for biometric identification and certain other cases. Getting this wrong blocks market access.
Article 17 requires providers of high-risk AI systems to implement a quality management system. Rather than building something completely new, we help you integrate AI Act requirements into existing QMS frameworks (ISO 9001, ISO 13485, etc.)—leveraging your current processes while filling the AI-specific gaps.
Beyond initial compliance, we help you embed principles of trustworthy AI (fairness, transparency, robustness) and establish robust AI governance frameworks, including the necessary post-market monitoring systems and reporting structures required by the Act.
"Human in the loop" is not a magic shield. The AI Act requires meaningful human oversight—humans who understand the system, have time to review its outputs, and can override decisions when necessary. We design oversight mechanisms that satisfy regulatory requirements while remaining practical for your operational context.
The AI Act mandates transparency obligations that go beyond GDPR—users must know they're interacting with AI, understand the system's capabilities and limitations, and be informed about decision-making logic. We help you translate these requirements into clear, practical disclosures that don't overwhelm users.
Compliance doesn't end at deployment. Article 61 requires ongoing post-market monitoring to detect emerging risks, performance degradation, or unintended consequences. We design monitoring systems that catch issues early, satisfy reporting obligations, and create feedback loops for continuous improvement.
Sustainable compliance requires embedding AI governance into your organizational DNA—not just checking boxes, but building a culture of responsible AI use. We help you develop policies, procedures, and governance structures that ensure long-term compliance while enabling innovation and competitive advantage.
Ready to embrace AI responsibly in the EU? Our expertise ensures you meet regulatory demands and build trust.
Client identities are withheld at their request.
We were building a high-risk AI system for clinical decision support and had no idea how to navigate the Act's obligations. The gap analysis and compliance roadmap gave us exactly what we needed to proceed with confidence.
The team translated dense legal text into specific technical and organisational measures our engineers could actually implement. That bridging expertise is genuinely rare.
We thought we were mostly compliant — the assessment showed us three critical gaps we would have missed until enforcement. We closed them well before the deadline.
Don't wait for enforcement. Understand your obligations under the EU AI Act and start your compliance journey today.
Get Your AI Act ConsultationWhether you have a clear project in mind or just a nagging question about where AI or process improvement could take your business — write to us. We read every message personally and respond within one business day.