Regulatory Signal Intelligence
A comprehensive regulatory signal layer covering FDA 510(k), EUDAMED, ANVISA, NMPA, PMDA, and 24 global data sources — part of the Contextual Intelligence Platform.
Track certificates, approvals, recalls, and compliance signals in real time.
Data Sources
Regulatory data from every major market
North America
- FDA (USA) — 510(k), PMA, De Novo, recalls
- Health Canada — MDALL, device licenses
- USPTO — patent filings and grants
Europe
- EUDAMED — IVDR/MDR certificates, NB decisions
- EU CTIS — clinical trial registry
- EPO — European patent filings
- WHO Prequalification
Asia-Pacific
- NMPA (China) — device registrations
- PMDA (Japan) — premarket approvals
- MFDS (South Korea) — certifications
- TGA (Australia) — ARTG listings
Latin America & More
- ANVISA (Brazil) — device registrations
- COFEPRIS (Mexico) — sanitary authorizations
- INVIMA (Colombia) — device registry
- ANMAT (Argentina) — device approvals
How It Works
From raw regulatory data to actionable intelligence
Signal Collection
Continuous monitoring of 24 regulatory data sources, including FDA, EUDAMED, ANVISA, PMDA, and more. Updated in real time.
Graph Analysis
Semantic knowledge graphs map relationships between regulatory events, companies, products, and notified bodies — revealing patterns invisible to manual research.
Actionable Alerts
Real-time notifications for certificate expirations, competitor clearances, regulatory changes, and compliance deadlines — delivered to your dashboard.
Key Capabilities
IVDR/MDR Certificate Tracking
Monitor 3,334+ IVDR certificates across 20+ notified bodies. Track transitions, expirations, and new issuances in real time.
FDA 510(k) & PMA Intelligence
Track every FDA clearance and approval. Identify competitor device clearances, recall patterns, and market authorization trends.
Global Market Entry Signals
Identify when competitors enter new markets — NMPA registrations in China, PMDA approvals in Japan, ANVISA filings in Brazil.
Compliance Deadline Alerts
Never miss a regulatory deadline. Automated alerts for IVDR 2027 transitions, certificate renewals, and submission windows.
Start Monitoring Regulatory Signals
Turn regulatory noise into competitive advantage. Our signal intelligence platform monitors global public sources so you can focus on strategy.