ReguAI – AI-Powered Compliance Automation for EU Medical Device Manufacturers

SaaS platform automating EU AI Act compliance for medical device developers through real-time regulatory monitoring, documentation automation, and audit trail creation.

ReguAI addresses the €2.3B EU compliance software market by automating 80% of regulatory workflows for AI-powered medical devices. The platform reduces certification timelines by 40% while cutting legal costs through machine learning-powered risk classification and real-time regulation tracking.

Core Functionality

  • Automated documentation generation for Technical Files
  • Continuous monitoring of EU AI Act/MDR updates
  • Jira/GitLab integration for compliance-by-design development
  • Automated audit trail creation with version control
  • AI-powered risk classification (Class I-IV devices)

Target User Segment

Primary clients: 50-200 employee healthtech companies developing AI diagnostics. Initial focus on German/French manufacturers requiring MDR+IVDR compliance. Secondary users: Compliance officers at medical device CROs.

Recommended Tech Stack

  • Python/Django backend with Celery task queue
  • React dashboard with Three.js compliance visualization
  • AWS GovCloud HIPAA-compliant hosting
  • TensorFlow NLP for regulation analysis
  • Jira/Confluence API integrations

MVP Development Costs

Total €80k-€100k over 6 months:

  • Core compliance engine: €25k
  • Document automation: €18k
  • Security/audit features: €12k
  • Third-party integrations: €10k

SWOT Analysis

Strengths First AI-specific compliance tool
Weaknesses High legal review dependencies
Opportunities EU digital health grants
Threats Regulatory body adoption delays

Customer Acquisition Strategy

€600 CAC through:

  • Co-marketing with Notified Bodies (30% conversions)
  • LinkedIn ABM campaigns targeting MedTech CTOs
  • Free compliance score assessments

Monetization Model

Tiered pricing from €1,500/mo (startups) to €4,000/mo (enterprise). Break-even at 63 clients with 5-person team:

  • 2 Full-stack developers
  • 1 Compliance specialist
  • 1 Sales lead
  • 1 Customer success manager

Market Positioning

Differentiated from Greenlight Guru via real-time AI regulation mapping. Leverages partnerships with TÜV Rheinland during certification audits. Captures 3% of German medical AI market within 18 months.

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