AI Act compliance for healthcare

Diagnostic-support AI is high-risk and stacks with the MDR. Article 10 requires a data dossier: provenance, quality, cohort representativeness.

Your pain points

• Representativeness of cohorts (age, sex, origin) — demographic bias.
• Consent and legal basis for health data (GDPR, special category).
• The MDR + AI Act overlap.

What we do

In-place analysis (health data never leaves): representativeness, PII (including DICOM headers), quality, an Article 10 dossier.