Pre-market evidence for high-risk AI systems under the EU AI Act.
AIIA is a software platform for organisations that must show conformity with the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) for high-risk AI systems. It is built for pre-market readiness: the file a notified body or authority can sample, not a checklist of clauses.
For a South African organisation this page applies only where you are a provider placing a high-risk system on the Union market, putting one into service there, or producing output that is used in the Union. POPIA still governs any personal information in the same system. A PIIA under Regulation 4(1)(b) is a different file. AIIA does not replace it. A Fundamental Rights Impact Assessment under Article 27, where that article applies, does not discharge POPIA either.
The platform integrates obligations from the AI Act, and from GDPR where Union people are in the file, with harmonised-standard practice including prEN 18286 for an AI quality management system.
Multi-role collaboration (preparer, reviewer, approver) lets technical, legal and compliance teams, and external parties such as providers and suppliers, contribute to the system description, technical documentation, risk assessment, controls and acceptance.
From the work as it is done, AIIA generates the documents required for conformity assessment: technical documentation aligned with Annex IV, an EU declaration of conformity aligned with Annex V, a Fundamental Rights Impact Assessment where Article 27 applies, a post-market monitoring plan under Article 72, and a residual-risk acceptance statement.
AIIA is delivered as a cloud platform. Request a walkthrough of the assessment for a named high-risk system, or download the brochure.