Medical AI · DSGVO & MDR
Healthcare AI: GDPR/MDR-compliant clinical workflows
We design medical AI tooling where compliance is a first-class requirement — auditable, documented, and built for regulated environments.
Clinical-grade, compliance-first
From signal processing to imaging, we build pipelines that are auditable and aligned with healthcare regulation from the start.
- EEG and biosignal analysis
- Medical imaging pipelines
- GDPR/MDR-aware, ISO 27001-aligned controls
Auditability by design
Documented change control, validation templates, and traceable decisions keep every deployment auditor-ready.
- Validation and documentation templates
- Access control and data-residency options
- Traceable model and data lineage
FAQ
Are you a medical device manufacturer?
We build software and tooling and work MDR-aware alongside your regulatory team; we are not a notified body. We help you stay audit-ready.
Can data stay in the EU / on-premise?
Yes. EU hosting is the default and on-premise deployment is supported for sensitive clinical data.
Compliance-grade healthcare AI
Book a call to discuss your clinical or research AI use case and its compliance requirements.
More services