SCIENTIA ET LEX

AI Conformity Assessment Implementation

Systematic conformity assessment methodology for high-risk AI systems. Technical validation, regulatory compliance verification, and CE marking implementation under EU AI Act requirements.

99.7%

Compliance Coverage

6-8 Weeks

Implementation Timeline

CE

Market Certification

Systematic Conformity Assessment Framework

Technical methodology for EU AI Act compliance verification and CE marking implementation

1

Technical Documentation Review

Documentation validation, risk management system assessment, and compliance verification against EU AI Act requirements

2

Technical Validation & Testing

Performance assessment, bias detection, security validation, and functional requirement verification with human oversight testing

3

Risk Assessment & Mitigation Validation

Comprehensive risk scenario evaluation, stakeholder impact assessment, and control effectiveness validation

4

CE Marking & Declaration of Conformity

EU declaration preparation, technical documentation compilation, and market surveillance compliance setup

Assessment Types & Technical Deliverables

Internal Assessment (Annex VI)

Applicable for standard high-risk AI systems • 6-8 weeks implementation

  • • Quality management system verification
  • • Technical documentation validation
  • • Internal testing and compliance confirmation
  • • EU declaration of conformity preparation

Third-Party Assessment (Annex VII)

Required for biometric and critical systems • 8-12 weeks implementation

  • • Notified body assessment coordination
  • • Independent technical evaluation
  • • External validation and testing
  • • Third-party certification management

Technical Deliverables

Compliance: Technical file compilation, risk management documentation, quality system evidence
Validation: Performance testing results, compliance verification reports, risk assessment validation
Certification: EU declaration of conformity, CE marking documentation, market surveillance procedures

Conformity Assessment Implementation

What determines internal vs third-party conformity assessment requirements?

Annex III high-risk systems require internal assessment (Annex VI), whilst biometric identification and critical infrastructure systems mandate third-party assessment through notified bodies (Annex VII).

How long does systematic conformity assessment implementation require?

Internal assessment implementation requires 6-8 weeks for documentation, testing, and declaration preparation. Third-party assessment extends to 8-12 weeks including notified body coordination and external validation.

What technical deliverables ensure market surveillance compliance?

Complete technical file compilation, validated risk management documentation, performance testing reports, EU declaration of conformity, and post-market monitoring procedures ensure regulatory compliance.

Professional Conformity Assessment Consultation

Technical conformity assessment implementation necessitates systematic methodology combined with regulatory expertise to ensure market compliance and penalty avoidance.

Assessment Readiness Implementation Support

Systematic implementation • Regulatory expertise • Market certification