Understanding the EU AI Act: A Comprehensive Guide for Organizations
A detailed analysis of the EU AI Act requirements and their implications for businesses deploying AI systems in regulated industries.
Trustworthy AI Solutions for Regulated Industries
We design and deliver practical, trustworthy AI-driven solutions that help organizations solve real problems, improve decision-making, and build sustainable digital systems. Compliant with EU AI Act and GDPR requirements.
About FormalTrust AI
Delivering practical, trustworthy AI-driven solutions
Design and deliver practical, trustworthy AI-driven and information technology solutions that help organizations solve real problems, improve decision-making, and build sustainable digital systems.
We partner with organizations in regulated industries to implement AI solutions that meet compliance requirements while driving operational excellence.
We are guided by trust, responsibility, transparency, scientific rigor, and a strong commitment to data protection and human oversight.
Every solution we build prioritizes explainability, auditability, and compliance with regulatory frameworks including the EU AI Act and GDPR.
Our team brings deep expertise in AI/ML engineering, formal methods, security & GDPR compliance, product design & UX, backend infrastructure, regulatory compliance, and clinical domain knowledge.
We combine academic rigor with practical industry experience to deliver solutions that work in the real world.
Products
AI-Driven Solutions for Regulated Industries
Our products are designed with compliance, traceability, and transparency at their core, helping organizations meet regulatory requirements while improving efficiency.
Auditiva - Clinical Workflow
Structured documentation support via speech-to-text translation, improved traceability and auditability, reduced administrative workload, and transparent session histories for healthcare professionals.
Learn More →PDF & Documentation Tools
Automated generation of structured, versioned PDF reports with agentic AI. Configurable templates aligned with organizational and regulatory needs, time-stamped documentation with full change history.
Learn More →AI-Driven Predictive Maintenance
Real-time monitoring of systems, AI-based prediction of potential failures and maintenance needs. Explainable alerts and recommendations with human-in-the-loop validation.
Learn More →Who We Help
Industries We Serve
We partner with organizations in regulated industries to implement trustworthy AI solutions that meet compliance requirements and drive operational excellence.
Healthcare & Life Sciences
AI-powered diagnostics and clinical decision support systems that meet strict healthcare regulations including MDR and FDA requirements.
Learn MoreOrganizations & SMEs
Scalable AI audit and compliance solutions designed for enterprises and growing businesses preparing for EU AI Act requirements.
Learn MoreIndustrial & Robotics
Predictive maintenance and autonomous systems validation for manufacturing, automotive, and robotics industries with safety certifications.
Learn MoreRegulation & Compliance
Expert guidance for notified bodies and regulatory authorities implementing AI Act compliance frameworks and certification processes.
Learn MoreReady to Build Trustworthy AI?
Join leading organizations in healthcare, manufacturing, and technology who trust FormalTrust AI to ensure their AI systems meet regulatory requirements and operational excellence standards. Let's discuss how we can help you navigate the EU AI Act and beyond.
Team
Leadership Team
Our leadership brings together deep expertise in AI safety, formal methods, and regulatory compliance to deliver trustworthy AI solutions.
Dr. Mohammad Loni
Co-founder
PhD in Embedded Systems, expert in AI safety and formal verification with 10+ years research experience.
Dr. Masoud Ebrahimi
Co-founder
PhD in Computer Science, specializing in machine learning systems and AI infrastructure architecture.
Advisory Board
Industry leaders and academic experts guiding our strategic vision and technical direction.
Partners & Funding
Trusted By Industry Leaders
We collaborate with leading organizations and are supported by prestigious funding bodies to advance trustworthy AI solutions.
Research Partners
Funded By
FAQ
Frequently Asked Questions
Get answers to common questions about AI compliance, the EU AI Act, and how FormalTrust can help your organization.
What is the EU AI Act and how does it affect my business?
The EU AI Act is the world's first comprehensive regulatory framework for artificial intelligence. It establishes requirements for AI systems based on their risk level, with high-risk systems requiring conformity assessments, documentation, and ongoing monitoring. If you develop or deploy AI in the EU market, compliance is mandatory.
How does Auditiva help with AI compliance?
Auditiva is our AI audit platform that provides automated compliance assessment against EU AI Act requirements. It analyzes your AI systems for bias, transparency, robustness, and security, generating detailed reports and actionable recommendations for achieving compliance.
What industries do you specialize in?
We specialize in highly regulated industries including healthcare and life sciences (MDR, FDA compliance), industrial manufacturing and robotics, automotive, and financial services. Our solutions are designed to meet the stringent requirements of these sectors while enabling innovation.
How long does an AI compliance assessment take?
The timeline depends on the complexity of your AI system and current documentation state. A basic assessment typically takes 2-4 weeks, while comprehensive audits for high-risk systems may require 2-3 months. Contact us for a customized timeline based on your specific needs.
Resources
Publications & Insights
Stay informed about the latest developments in AI compliance, trustworthy AI research, and regulatory updates from our team of experts.
Formal Methods for AI Safety: Best Practices and Implementation
Explore proven formal verification techniques for ensuring AI system reliability, safety, and compliance with industry standards.
Healthcare AI Compliance: A Success Story
How a leading healthcare provider achieved MDR compliance for their AI-powered diagnostic system using FormalTrust solutions.
Get in Touch
Request a Demo or Consultation
Ready to explore how FormalTrust can help your organization achieve AI compliance? Fill out the form below and our team will get back to you within 24 hours.