For high-risk HR-tech AI-systemer der falder under Article 6 + Annex III: Article 43 conformity assessment + Annex IV technical documentation + notified-body koordinering. Custom pris, custom timeline.
Article 43 conformity assessment
Internal control (Article 43(1)(a)) eller notified-body involvement (Article 43(1)(b)) afhængigt af AI-system-type. PowerQuant koordinerer dokumentations-pakken; notified-body's egen audit udføres af DA/EU akkrediteret org.
Annex IV technical documentation
Komplet 12-sektions Annex IV technical documentation: general description, detailed description, monitoring/functioning/control, risk management system, data + data governance, validation + testing procedures, cybersecurity, post-market monitoring, declaration of conformity.
FRIA — Fundamental Rights Impact Assessment
Article 27 FRIA for high-risk deployers i offentlige eller specific kontekster. Vurderer impact på fundamental rights (non-discrimination, privacy, due process, dignity). Koordineret med GDPR Article 35 DPIA.
Article 26 deployer obligationer
For deployere af third-party high-risk AI: monitoring, human oversight maintenance, log-keeping, transparens til affected persons, automatic decision-making documentation. Module 3 leverer deployer-checklist + ongoing monitoring-template.
Post-market monitoring (Article 72)
Plan + procedurer for continuous monitoring af AI-systemets performance, drift, incidents. Article 73 incident-rapportering inden 72 timer ved serious incident. Module 3 inkluderer template + workflow.