MediGuard
Start free โ†’
EU AI Act Compliance ยท Enforcement from 2 Aug 2026

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. Regulators gain enforcement powers on 2 August 2026 โ€” know where you stand before they do.

No credit card required ยท Risk Classifier always free

GDPR Ready Healthcare AI Specialist EU AI Act Native Annex IV Templates GPAI Coverage (Art. 53/55) Multi-user Teams

The smarter path to CE marking

EU AI Act fines reach up to โ‚ฌ35M or 7% of global turnover. MediGuard gives your team a clear, systematic path through Annex IV technical documentation without hiring an in-house regulatory affairs department. The Digital Omnibus moved Annex III obligations to December 2027 โ€” but enforcement powers and the GPAI regime arrive on 2 August 2026. Use the runway.

  • Zero medical liability โ€“ you manage documents, not diagnoses
  • EU AI Act Annex IV template compliance built-in
  • Reduce documentation time from months to hours
  • Audit-ready PDF export for every Technical File
  • Invite teammates โ€” documentation, gap analysis, and classifier history shared across your org
  • Enterprise-grade data security and access controls

Zero Medical Liability

You handle documents; your client handles clinical decisions.

โ‚ฌ35M 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.

Built for compliance teams

Invite colleagues, assign roles, and collaborate on documentation and gap analysis โ€” all changes sync across your entire team in real time.

Invite by email

Add colleagues in one click. They join your shared workspace instantly.

Shared workspace

Documentation, gap analysis, and classifier history visible to every active team member.

Role management

Owner and admin roles control who can invite, remove, or manage team membership.

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)
  • Team accounts & shared workspace
  • PDF export
  • Priority support

Enterprise

Customper year
  • Everything in Growth
  • Unlimited Summarizer runs
  • SSO & role-based access
  • Dedicated compliance advisor
  • SLA + on-premise option
Contact sales

Need more? Talk to us.

  • Unlimited Summarizer runs
  • SSO & role-based access
  • Dedicated compliance advisor
  • SLA + on-premise option
Contact sales โ†’

hello@mediguard.solutions

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