AI-powered compliance platform for medical ML systems offering real-time auditing, bias detection, and regulatory documentation aligned with FDA/EU standards. Targets MedTech developers with Class II/III devices.
CompliGuard AI addresses the $2.1B medical AI compliance gap through automated documentation and bias monitoring. Designed for developers of surgical training systems and diagnostic tools, it reduces regulatory approval timelines by 40% while maintaining audit-ready status across 23 healthcare jurisdictions.
Core Functionality
- Real-time decision tracking with blockchain audit trails
- Automated FDA 510(k)/EU MDR documentation generator
- Bias detection algorithms monitoring demographic parity
- Interactive compliance dashboard with risk heatmaps
Target User and Segment
Primary customers: Medical AI startups (70%) and hospital IT departments (30%). Initial focus on US diabetes prediction tools ($340M segment) and EU surgical robotics compliance ($410M market).
Recommended Tech Stack
- Python ML stack with TensorFlow Model Cards
- Hyperledger Fabric for immutable logs
- React-based compliance UI
- AWS GovCloud HIPAA hosting
Estimated MVP Costs
€50k base development (500h @ €100/h):
• Compliance engine: 200h
• Regulatory templates: 120h
• Audit API: 150h
+ €10k for FDA pre-submission module
SWOT Analysis
- Strengths: First specialized solution for AI medical devices
- Weaknesses: Dependency on regulatory changes
- Opportunities: Partnership with notified bodies
- Threats: IBM Watson expanding into niche
First 1000 Customers Strategy
1. Co-marketing with AI annotation platforms (45% conversions)
2. Compliance hackathons for MedTech startups
3. Free audit reports for FDA pilot participants
CPA: €150 via LinkedIn surgical AI groups
Monetization Model
- Tiered SaaS: €1.5k-€4.5k/month
- Break-even at 187 customers (14 months)
- Team: 3 compliance engineers + GRC specialist
Market Positioning
Differentiated through surgical AI templates vs IBM’s general health tools. Sales via MedTech conferences and co-branded whitepapers with EU certification bodies.
