Comforma Compliance

High-Risk AI System Assessment

Your first step to full EU AI Act compliance

Every AI system must be classified. We deliver a clear, defensible risk assessment for each model or system—plus concrete next steps if it is high-risk—so you avoid misclassification, delays, and fines.

Why this matters

Classification is mandatory
Required by the AI Act

Every system must be assessed; classification dictates all downstream obligations.

Misclassification is expensive
Delays & procurement friction

Wrong tier leads to wrong controls and potential market withdrawal.

Penalty exposure
Avoid enforcement risk

Get the decision and evidence right early to avoid revenue-scaled fines.

Why this assessment - Why Conforma Studio

Led by a lawyer and software engineer, with documentation you can show to procurement, auditors, and regulators.

  • Law × Engineering

    We match regulatory definitions to real architectures, data flows, and model behavior.

  • Defensible outcomes

    Clear reasoning, Annex references, and evidence links you can show.

  • Precision

    Borderline cases handled. We flag gray areas and reclassification risks early.

  • Speed

    Focused intake, fast iteration, final document ready for procurement and compliance.

  • Roadmap

    A practical action plan covering documentation, risk management, testing, and notified-body path.

What you get - A professional, regulator-ready assessment

A defensible classification with the legal basis, technical rationale, and evidence links—ready to live in your technical file and to answer procurement, auditors, and regulators.

Risk tier decision
Clear classification aligned to AI Act scope and definitions.
Annex mapping
Traceable mapping against Annex III high-risk categories.
Borderline analysis
Flags reclassification hazards and dependency risks.
Evidence list
Inputs reviewed, assumptions, and references you can show.
Action plan
If high-risk, stepwise obligations and owners.
Time to value
Fast turnaround from kickoff to signed deliverable.

How it works

Step 1 — Kickoff and scoping (30–45 min)

We map purpose, users, data, model type, integrations, deployment, and markets served.

  • Roles: provider, deployer, user, importer
  • Intended purpose and context of use
  • Architecture and data flow overview
Step 2 — Legal–technical analysis

We test your facts against AI Act scope and Annex III categories; we assess borderline cases.

  • Scope & exclusions screening
  • Annex III category tests
  • Reclassification risk flags
Step 3 — Assessment document (draft → final)

You receive the full write-up with rationale and implications for obligations.

  • Risk tier decision and reasoning
  • Evidence and assumptions list
  • Review session and edits
Step 4 — Next steps if high-risk

A prioritized roadmap aligned to the Act’s obligations and your delivery plan.

  • Technical documentation (Annex IV)
  • Risk management, testing, post-market
  • Notified body & conformity path

Avoid the million-euro mistake.

Get a defensible classification and a practical roadmap if your system is high-risk. Built by a lawyer and software engineer, ready for procurement and regulators.

Request assessment

Booking - Request your session

Share your goals with us and discover how we can guide you through complex compliance requirements.

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