Pre-Assessment & High-Risk AI Audit

Independent Assessment under the EU AI Act

We assess the regulatory readiness of your High-Risk AI systems, reviewing controls, documentation, and technical evidence to identify gaps before a conformity assessment or regulatory request.

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Why Is a Pre-Assessment Essential Before Conformity Assessment?

High-Risk AI systems are subject to enhanced obligations under the EU AI Act. Before undergoing a conformity assessment, external audit, or regulatory request, it is essential to understand the system’s actual level of regulatory readiness.

A preliminary assessment helps identify gaps in risk management, data quality, technical documentation, Human Oversight, and accuracy, robustness, and cybersecurity controls, reducing both regulatory and operational risks.

I’ve adjusted the heading rather than translating “the first indispensable step” literally, because—as we established earlier—the first step is risk classification, not the Pre-Assessment.

What Do We Audit in the EU AI Act Pre-Assessment?

  • 1. Risk Management System
  • We review the existence, design, and implementation of measures to identify, assess, and mitigate risks throughout the system lifecycle.
  • 2. Data Governance, Quality, and Traceability
  • We assess data provenance, data quality, applied controls, and the traceability required to support regulatory compliance.
  • 3. Technical Documentation and Records
  • We review the technical documentation, records, logs, and evidence required to support the operation and oversight of the system.
  • 4. Human Oversight and Technical Controls
  • We assess Human Oversight mechanisms, together with applicable accuracy, robustness, and cybersecurity controls.
  • 5. Compliance Gap Identification
  • We identify deviations from the applicable requirements of the EU AI Act and prioritize the corrective actions required.
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Deliverables

  • 1. Pre-Assessment & Gap Analysis Report
  • Aicertia document outlining the system’s level of readiness, the evidence reviewed, and the deviations identified against the applicable requirements. 2. Prioritized Remediation Plan
  • A roadmap defining corrective actions, priorities, and next steps to progress toward compliance with the EU AI Act for High-Risk AI systems.

EU AI Act Compliance

Ensure that the use of AI operates within a governance and compliance framework aligned with European regulation.

Certified Professional Competence

Assess and document the competencies of professionals responsible for using and supervising AI systems.

Traceability & Verification

Maintain verifiable evidence, credentials, and records to support audits and internal governance processes.

Drive Technological Excellence Across Your Organization

We design tailored corporate certification plans based on your organization’s size and needs, with preferential conditions and priority technical support.

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