When Do You Need a High-Risk Pre-Assessment?
When an AI system may be classified as High-Risk, it is necessary to determine which requirements apply based on the specific use case, the organisation’s role, and how the system is developed or used.
Aicertia’s Pre-Assessment provides a clear view of the current level of readiness, identifies technical, documentary, and organisational gaps, and helps prioritise the actions required before moving towards the full implementation of controls or, where applicable, a conformity assessment.
What Do We Assess in the Pre-Assessment?
- Risk Management – We review the mechanisms in place to identify, analyse, evaluate, document, and manage risks associated with the AI system throughout its lifecycle.
- Data and Data Governance – Where applicable, we assess the origin, quality, representativeness, traceability, and controls established over the data used by the system.
- Documentation and Records – We review the available documentation, instructions for use, records, logs, and evidence required to support traceability and compliance.
- Human Oversight – We assess responsibilities, oversight mechanisms, intervention capabilities, and procedures established for the safe use of the system.
- Accuracy, Robustness and Cybersecurity – We review the existing evidence and controls related to expected performance, robustness, resilience, and system security.
- Transparency and Information – We analyse the information available to users and deployers, as well as any transparency obligations that may apply.
- Roles and Responsibilities – We determine the organisation’s responsibilities based on its role in the AI value chain and review the internal allocation of responsibilities.
- Regulatory Gap Analysis – We identify the differences between the current situation and the requirements assessed, classifying findings by criticality and priority.
Deliverables
- Pre-Assessment Report
Structured assessment of the system’s level of readiness against the regulatory requirements analysed. - Gap Analysis
Detailed record of identified gaps, outstanding evidence, detected deficiencies, and the criticality level of each finding. - Priority Matrix
Classification of required actions according to regulatory impact, urgency, and implementation effort. - Remediation Roadmap
Roadmap outlining the recommended actions and next steps required to progress towards compliance.
What Result Do You Get?
| Area | Example Result |
|---|---|
| Risk Management | 🔴 Critical Gap |
| Data Governance | 🟠 Improvement Required |
| Documentation | 🟠 Partial |
| Human Oversight | 🔴 Insufficient |
| Logging | 🟢 Adequate |
| Robustness and Security | 🟠 Evidence Pending |
The objective is to provide a clear picture of the system’s current level of readiness and turn the findings into an actionable implementation plan.
Pricing
- EU AI Act High-Risk Pre-Assessment
From €3,900
The final scope depends on the AI system assessed, the organisation’s role, the available documentation, the technical complexity, and the depth of assessment required. - Aicertia’s Pre-Assessment is an independent readiness and gap analysis. It does not, by itself, constitute an official certification or a declaration of conformity with the EU AI Act.
Prepare Your High-Risk AI System for Compliance
Identify gaps, prioritise remediation actions, and build a clear roadmap towards meeting the applicable requirements of the EU AI Act.
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