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.