EU AI Act Compliance

The EU AI Act (Regulation (EU) 2024/1689) is the world's first comprehensive AI regulation. Ketryx helps teams meet the risk-based obligations without replacing the tools they already use.

What does the EU AI Act Require?

Classify by risk. Prove conformity

The EU AI Act requires high-risk systems to complete conformity assessments, maintain technical documentation, and register in the EU database. CE marking follows the AI Act or the applicable sectoral regulation.

Be continuously compliant

The EU AI Act makes risk assessments, post-market monitoring, and documentation ongoing obligations across the full AI lifecycle.

Oversight built in, not bolted on

The EU AI Act requires high-risk systems to support human oversight, minimize bias under Article 10, and enable traceability through the documentation and logging required by Articles 11 and 12.

Are You Ready for the EU AI Act?

The regulation imposes compliance obligations across the entire AI supply chain: providers, deployers, importers, and distributors.

• Risk classifications must be traced to mitigations and test results.
• Training data, model decisions, and outputs must be documented and auditable.
• Human oversight and technical documentation must be built in from day one.

How Ketryx can help

Ketryx makes EU AI Act compliance part of the development workflow, not a separate workstream, integrating risk management, traceability, and technical documentation into the tools your teams already use.

Automated documentation and end-to-end traceability for EU AI Act Article 11

Article 11 requires documentation on system design, methodology, risk management, and performance. Ketryx generates version-locked documents from live project data and builds a real-time traceability matrix across connected systems.

AI risk management aligned with Article 9

Article 9 requires a risk management system across the AI lifecycle. Ketryx connects identification to mitigation, verification, and monitoring.

Quality management system for Article 17

Article 17 requires a QMS covering development, data management, risk management, change control, and post-market monitoring. Ketryx enforces it with engineering controls in your existing workflows.

Independent obligations for deployers under Article 26

Article 26 obliges deployers to: designate competent human oversight personnel, ensure input data quality where they control inputs, monitor the system during use, conduct fundamental rights impact assessments (required for public bodies and certain private entities under Article 27), and retain automatically generated logs for at least six months. On a serious incident, deployers must immediately notify both the provider and the market surveillance authority.

Ketryx Assistant

The Ketryx Assistant generates compliant artifacts, analyzes traceability, and answers QMS questions using your actual project data, including your requirements, risks, tests, and design history, instead of generic training sets. Originally built for FDA-regulated work, these capabilities apply directly to EU AI Act high-risk AI system obligations under Title III.

Continuous monitoring and incident reporting

Providers must establish post-market monitoring and report serious incidents within Article 73 timeframes.

How Aignostics is Accelerating AI Development with Ketryx

Aignostics is a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights. With an expanding portfolio of AI-powered pathology products, Aignostics needed a streamlined, integrated solution to support their regulated software development processes and ISO 13485 certification. By transitioning to Ketryx, Aignostics was able to cut their release time down to three months while staying compliant.

Preparing for the EU AI Act?

Get started in minutes, not months.