AI-powered compliance platform automating FDA/EU regulatory alignment for medical AI diagnostics, reducing certification timelines by 40% through real-time monitoring and automated documentation.
As AI diagnostic tools face increasing regulatory scrutiny, ReguLens AI emerges as a critical compliance layer for medical device manufacturers. This cloud platform automates real-time alignment with 50+ global standards, addressing the $4.3B regulatory tech market through specialized AI interpretation of complex medical regulations.
Core Functionality
- Real-time monitoring of AI algorithms against FDA/EU MDR standards
- NLP-powered compliance engine generating gap analysis reports
- Integrated certification templates for 510(k)/De Novo submissions
- Blockchain-backed audit trails for regulatory decisions
Target User and Segment
Primarily serves 2,100+ MedTech firms developing AI diagnostic tools, focusing on US/EU markets. Secondary users include regulatory teams at medical imaging companies managing PI-RADS compliance.
Recommended Tech Stack
- AWS GovCloud HIPAA environment
- TensorFlow NLP models trained on regulatory documents
- Hyperledger Fabric for audit trails
- HL7 FHIR-compliant REST APIs
Estimated MVP Costs
1,200 development hours (€120,000 ±15%) covering:
- Cloud infrastructure setup (€16k)
- Compliance engine development (€32k)
- QMS integration module (€24k)
SWOT Analysis
- Strengths: First-mover advantage in AI compliance automation
- Weaknesses: Dependency on regulatory API access
- Opportunities: €1.2B IVDR diagnostics expansion
- Threats: Legacy QMS platforms adding similar features
First 1000 Customers Strategy
18-month acquisition through:
- LinkedIn ads targeting regulatory managers (€8k/mo)
- TÜV SÜD co-marketing partnerships
- Free compliance audits for top AI imaging firms
Target CAC: €500 with 3% trial conversion rate.
Monetization
Tiered subscriptions from €1,500-15,000/mo per AI model. Break-even at 240 customers (€3.6M ARR) with 72% gross margins. Core team: 6 FTEs including compliance experts.
Market Positioning
Differentiates through real-time AI compliance in €4.3B regulatory tech market. Outperforms manual solutions like Greenlight Guru with automated PI-RADS v2.1 alignment for prostate cancer diagnostics.
