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Innopulse Consulting

High-risk conformity under the EU AI Act

Providers and deployers of high-risk AI systems that must meet the full obligations of the EU AI Act.

Updated: 2026-09

In short

This package brings a high-risk AI system to conformity under the EU AI Act: risk management, data governance, technical documentation to Annex IV, human oversight and logging — built as an audit-ready dossier that carries through to CE marking and registration.

Making a high-risk AI system conformant is not a document but a system of risk management, data quality, documentation, oversight and logging that must interlock. Anyone starting shortly before the enforcement window finds that many records only exist if they were kept from the outset.

This package builds exactly that system — structured, audit-ready and with the AI Act’s staggered deadlines in view.

What you get

Risk management system

Built to Article 9, documented and kept alive.

Technical documentation

A complete dossier to Annex IV.

Oversight and logging concept

Human oversight and record-keeping to Articles 12 and 14.

Conformity roadmap

The path to the declaration of conformity, CE marking and registration.

How it runs

  1. 01

    Classification

    Confirming the high-risk classification and the scope.

  2. 02

    Gap analysis

    Comparing the current state against the high-risk obligations.

  3. 03

    Build

    Producing documentation, risk management, oversight and logging.

  4. 04

    Audit readiness

    Finalising the dossier and handing over the roadmap to CE and registration.

Price framing

As an engagement or a package. We discuss scope and price range in a first conversation and put both in writing.

Indicative, not a binding quote — the frame is confirmed during scoping.

What drives the price? → Cost guide

Parent service: EU AI Act & Compliance Advisory

FAQ

From when must we be conformant?

For most high-risk systems the obligations apply on a staggered basis from August 2026. The build takes months — starting now is decisive.

Does this replace legal advice?

No. We deliver the technical and organisational conformity; on borderline legal questions we bring in legal advice or recommend it.

What if we are not high-risk at all?

Then we clarify that first, often through a gap assessment. Not every system is high-risk, and misclassification in either direction is expensive.

LM
Reviewed by
Founder & CEO · MSc Innovation Management (FFHS) · Author of “Identity Over Discipline”
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High-risk conformity under the EU AI Act

Providers and deployers of high-risk AI systems that must meet the full obligations of the EU AI Act.