MediGuard
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EU AI Act Compliance

Ship your medical AI
without the regulatory nightmare.

MediGuard automates the mandatory EU AI Act documentation for healthcare AI โ€” turning months of paperwork into hours, so life-saving tools reach patients faster.

No credit card required ยท Risk Classifier always free

SOC 2 Type II GDPR Compliant HIPAA Aligned ISO 27001 Ready Annex VIII & IX Templates

The smarter path to CE marking

EU AI Act fines reach up to โ‚ฌ30M or 6% of global turnover. MediGuard gives your team a clear, systematic path through Annex VIII technical documentation without hiring an in-house regulatory affairs department.

  • Zero medical liability โ€“ you manage documents, not diagnoses
  • EU AI Act Annex VIII & IX template compliance built-in
  • Reduce documentation time from months to hours
  • Audit-ready PDF export for every Technical File
  • Role-based access for legal, clinical & engineering teams
  • SOC 2 Type II compliant data handling

Zero Medical Liability

You handle documents; your client handles clinical decisions.

โ‚ฌ30M Fine Prevention

Proactively close every gap the EU AI Act requires.

Audit-Ready Output

PDFs formatted to regulator expectations, every time.

LLM-Powered

Transform raw engineering logs into clear regulatory prose.

Simple, transparent pricing

Start free. Scale when you're ready.

Starter

Freeforever
  • Risk Classifier (unlimited)
  • 1 Documentation draft
  • Email support
Get started free
Most Popular

Growth

โ‚ฌ299/ month
  • Everything in Starter
  • Unlimited Documentation Files
  • Gap Analysis dashboard
  • Automated Summarizer (50 runs/mo)
  • PDF export
  • Priority support

Enterprise

Customper year
  • Everything in Growth
  • Unlimited Summarizer runs
  • SSO & role-based access
  • Dedicated compliance advisor
  • SLA + on-premise option
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Ready to get compliant?

Classify your AI system in under 5 minutes. Free forever, no card required.

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