AI Compliance
Explore our AI compliance services designed to help you move forward with confidence, wherever you are headed next.
Current Reality
Inaction creates risk
Non-compliance means fines up to €35 million or 7% of global turnover, operational disruptions, market restrictions and reputational damage. Every month without a compliance program increases your risk exposure. That is the cost of doing nothing.
AI is now regulated
The use and deployment of AI is regulated in EU and globally. Understanding these regulations is one thing. Turning them into concrete processes, roles, and decisions that actually work in your organization can be challenging.
Fast-paced but limited support
AI technology, as well as AI regulations, are constantly changing. In a fast-paced environment compliance often becomes fragmented. Organizations are left navigating complex requirements without clear precedents or practical resources tailored to their specific context.
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Why Regulyn?
We communicate clearly.
The regulation is complex enough. We explain the legal requirements without regulatory jargon or unnecessary complexity. We ensure you stay updated thoughout the engagement.
We make compliance work in practice.
We have spent over a decade working in regulated environments and understand how compliance efforts succeed or fail in real organizations. We turn legal requirements into actionable teams can actually implement.
We care about making you successful.
Our work is not done when we deliver documents. Our job is done when your team understands the requirements and you can demonstrate compliance with confidence. That is what we optimize for.
How we help
Any organization can meet AI regulation’s requirements effectively with the right guidance, documentation and practical governance structures. We help you achieve compliance efficiently without disrupting your operations.
AI Training
We deliver practical AI training for boards and staff.
Examples include board briefing on EU AI Act, AI literacy training for staff and role-based training (product, procurement).
AI Compliance Support
We support regulatory AI Compliance end to end.
Examples include role and risk level analysis, AI policies, governance roadmaps and compliance checklists.
Tailored Support
We offer tailored support for complex or high-stakes environments.
Some examples include AI deployment in patient care, replying to authorities requests and planning an international AI compliance program.
Make your operations compliant, not complicated.
Sector experience that makes a difference
We work across industries, but we bring deep knowledge in sectors where regulation is particularly complex. This sector knowledge means we understand your context from day one.
Research & Academia
We understand the unique challenges of environments where innovation must coexist with compliance. We know what matters in your environment.
Healthcare & Life Sciences
We understand how AI requirements layer onto clinical trials, patient care and medical devices. We know the regulatory intersections and how to navigate them efficiently.
Technology
We understand the varying needs of technology companies from startups to established corporations. We calibrate our approach to where you are.
Navigate EU AI Act with Confidence
The EU AI Act is now in force. Organizations across sectors are racing to understand what it means for them - and more importantly, how to comply without disrupting their operations.
You probably have questions. Which of your AI systems are affected? What documentation do you need? When do the deadlines actually apply to you? These are not simple questions. The AI Act is a complex, risk-based framework that intersects with sector-specific regulations, data protection law, and your organization's unique circumstances.
We turn that complexity into clarity. We assess your AI landscape, design practical governance structures, and offer actionable advice and practical compliance programs that work in the real world.
How we work
Assessment
We start by understanding your unique position , goals and challenges. Together, we define the next steps.
Implementation
We get to work and analyse the regulation, train your staff or plan governance models, depending on the project. Whenever possible, we work in close collaboration with you.
Handover
We ensure that you understand the deliverables and can use them in real life. We provide a written summary or review results in a meeting.
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Client Testimonials
What you Achieve
Trust and Control
Demonstratable compliance strengthens customer and investor trust. It also reduces exposure to fines, reputational harm and operational disruption.
Momentum
Compliance enables access to regulated markets. Clear rules, defined processes, and assigned responsibilities speed up decisions and reduce friction.
Readiness
Regulation will keep evolving, and strong governance helps you adapt without constant and costly rework. Building the foundation early delivers long-term value.
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Frequently asked questions (FAQ)
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The EU Artificial Intelligence Act is a new regulation that applies to all AI systems placed on the EU market or used within the EU. It is often referred to as (“AI Act”).
The AI Act introduces a wide range of obligations. The scope of these requirements depends on the organisation’s role (such as provider, deployer or distributor) and the system’s risk level. Non-compliance can result in administrative fines of up to €35 million.
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The EU AI Act requires organisations to maintain documentation proving the safety, transparency and compliance of their AI systems.
In practice, at minimum, this means:
AI system directory with system name, risk level and other key details;
documentation for safety/governance processes
transparency documentation
AI training material or log of trainings held (AI literacy)
an AI appendix for agreements, where relevant.
For high-risk AI, the documentation requirements are extensive, especially for providers. The key documentation includes technical documentation, risk management files and FRIA. Additionally, a conformity assessment and post-market monitoring plan may be required.
For general purpose AI-models (GPAIs) there are additional requirements. These include documentation covering models, training data, testing, risk mitigation, user guidance and monitoring.
More comprehensive guidance on documentation is available by requesting advisory support or visiting Regulyn Knowledge Center.
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The EU AI Act classifies AI systems into four risk categories.
Unacceptable Risk
AI systems that threaten fundamental rights are prohibited and cannot be developed or used in the EU.
Examples: AI used for social scoring or exploiting vulnerabilities of specific groups.High Risk
High-risk AI systems must meet strict requirements, including security, governance, transparency and documentation measures. Many AI use cases in healthcare, education, critical infrastructure and human resources fall into this category.
Examples: AI used for cancer detection, or systems used to assess job applicants.Limited Risk
Limited-risk AI systems are subject to transparency obligations. Users must be informed when they are interacting with an AI system.
Example: AI-assisted customer service chatbots
(Note: the public sector faces additional restrictions.)Minimal Risk
Minimal-risk AI systems are not subject to specific obligations under the AI Act.
Example: basic spam filtering. -
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Some obligations, such as the obligation to ensure adequate AI literacy and the prohibitions on certain AI use cases, are already applicable.
The provisions governing high-risk AI systems will enter into force next, with full applicability expected in 2026.
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Everything starts with a clear overview of how AI is currently used in your organisation. Begin by mapping your existing AI use cases. This allows you to prioritise systems based on their risk level.
A practical way to get started is to build on processes you already have in place, such as data protection risk assessments. It is also important to appoint a responsible person or team for AI governance.
In short: map your AI use, prioritise by risk and establish a governance process.
Tip: If you need clarity or more detailed guidance on AI governance, contact a Regulyn expert.
Contact us
If you are interested in working with us, complete the form with a few details about your situations and needs.
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