EU AI Act compliance for high-risk AI — delivered by a lawyer who builds software and a health expert who works inside AI systems, not outside them.
Book Your Free Assessment →The Compliance Clock Is Ticking
The EU AI Act is not a future concern — it is law. Since August 2024, the regulation has been rolling out in phases. By August 2026, companies deploying high-risk AI systems must demonstrate full compliance: risk assessments, technical documentation, human oversight, and ongoing monitoring. Non-compliance carries fines of up to €35 million or 7 % of global revenue.
If your AI touches health decisions, legal analysis, credit scoring, recruitment, or customer profiling, the EU classifies it as high-risk. That means your product needs a conformity assessment before it can operate in Europe — not after a regulator comes knocking.
The gap between awareness and action is where regulatory risk lives. We close it.
How We Get You Compliant
Not sure if the AI Act applies to you? Start here. We classify your AI system against the EU AI Act risk categories, identify which obligations apply, and deliver a clear report with prioritised next steps. You know exactly where you stand — and what to do first.
Full compliance, documented and audit-proof. We produce the complete technical documentation required under Annex IV, build your risk management system, design your human oversight framework, and prepare your conformity declaration. When the regulator asks, you hand them a folder — not an excuse.
Compliance is not a one-time project — it is an ongoing obligation. Our monthly retainer keeps your documentation current, monitors regulatory changes, and provides quarterly compliance reviews. You focus on building your product. We make sure it stays legal.
Industries We Serve
AI in healthcare is classified as high-risk under Annex III — and intersects with the Medical Devices Regulation. We bring a certified health practitioner's perspective to compliance, ensuring your product meets regulatory demands without losing clinical relevance.
Contract analysis, legal research tools, and document automation — if your AI advises on legal matters, it falls under the AI Act's most scrutinised category. Our founder is a practising lawyer with two decades in software conception. He evaluates your product from both sides.
Credit scoring, algorithmic trading, insurance risk models — financial AI carries some of the highest regulatory stakes under both the AI Act and DORA. The penalties are severe, but so is the competitive advantage of early compliance.
AI chatbots, booking recommendations, CRM profiling — hospitality companies often underestimate their transparency obligations under Article 50. If your AI interacts with guests, you need to disclose it. We help you get ahead of enforcement.
AI in hiring and performance evaluation is explicitly listed as high-risk. From CV screening to automated interview analysis — if your tool influences employment decisions, full compliance is mandatory.
AI systems managing energy grids, predictive maintenance, or resource allocation operate in a highly regulated space. The stakes are high, the budgets match, and the compliance requirements are non-negotiable.
Who We Are
German-licensed attorney with over twenty years of experience in software conception. Jens does not just understand the EU AI Act — he understands the systems it regulates. His career spans contract law, regulatory compliance, and the architecture of complex software products. As an expert reviewer for leading AI training platforms, he ensures that AI-generated legal content meets professional standards. For Pantareina's clients, he translates regulation into implementation — precise, actionable, and built to withstand audit.
Certified naturopath, health coach, and co-founder of Pantareina. Andrea brings the clinical perspective that purely technical consultants cannot offer. She reviews AI-generated health content for leading technology platforms, checking accuracy, safety, and alignment with established medical practice. For Health-Tech startups, she evaluates products from the practitioner's and the patient's point of view — bridging the gap between algorithm and bedside. Her focus: ensuring that AI in healthcare remains human-centred and genuinely beneficial.
The only EU AI Act consultancy that combines a licensed lawyer's regulatory expertise with a health practitioner's clinical judgment — the two fields the AI Act scrutinises most closely.
Both founders serve as expert reviewers for leading AI training platforms, evaluating legal and medical AI outputs daily. We do not just advise on compliance — we work inside the models.
A lean, remote-first boutique — no overhead, no billable-hour surprises. Fixed packages, clear deliverables, direct access to senior expertise. Every engagement is handled by the founders, not juniors.
Book a free 15-minute assessment. No pitch, no obligation — just a clear answer on whether your AI system is affected and what your next step should be.
Book Your Free Assessment → Or email us directly: jens@pantareina.com