Conformity Assessment, Ethical Design & Regulatory Compliance for AI Applications
This service provides a standardised ethical, legal, and technical review of AI models developed or validated with paediatric health data, aligned with current legislation and forthcoming EU Harmonised Standards. Activities include risk assessment of AI trained on paediatric data, conformity assessment and compliance support for medical devices (risk class ≥ IIa, EU 2017/745), and the integration of ethics-by-design principles tailored to children’s vulnerabilities. It also ensures continuous monitoring across the AI lifecycle—training, validation, deployment, and post-market use—through tools for compliance, dataset quality checks, and rigorous validation of algorithms, assumptions, protocols, and outputs.
