Regulatory Monitoring
Track regulatory activity across 24 global data sources in real time. From 510(k) clearances to IVDR certificates, know what changes before your competitors do.
Start Free TrialWhat We Monitor
Data sources across every major regulatory market, from the Americas to Asia-Pacific
North America
- FDA (USA) -- 510(k) clearances, PMA approvals, recalls, De Novo
- Health Canada -- MDALL, medical device licenses
- USPTO -- patent filings and grants
Europe
- EUDAMED -- IVDR 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) -- device certifications
- TGA (Australia) -- ARTG listings
Global & Specialized
- ANVISA (Brazil) -- device registrations
- WIPO -- international patent filings
- ClinicalTrials.gov -- global trials
- PubMed -- scientific literature
- Crunchbase, SEC -- funding data
Signal Types
18 signal types classified and scored in real time for immediate action
Regulatory Clearances
FDA 510(k), PMA, De Novo. IVDR certificates. CE marking under MDR. NMPA registrations.
Clinical Trials
New trial starts, phase changes, results postings, and study completions across registries.
Patent Activity
Patent filings, grants, and expirations across USPTO, EPO, WIPO, and national offices.
Funding Events
Series A through IPO, grants, and public market disclosures from MedTech companies.
Safety Notices
Recalls, field safety corrective actions, and adverse event reports from all major agencies.
Guideline Changes
Regulatory guidance updates, draft guidance, and policy shifts that affect your compliance path.
How It Works
From raw data to actionable intelligence in minutes
Continuous Crawling
Our crawlers poll global public sources 24/7, detecting new publications within minutes of release. Each source is monitored for format changes, new endpoints, and schema drift.
Classification & Scoring
Each new publication is classified into one of 18 signal types. A relevance score is calculated based on device category, market impact, and your configured priorities.
Enrichment
Signals are enriched with company profiles, device classifications, patent links, and historical context. Raw regulatory text becomes structured, searchable intelligence.
Alert Delivery
Alerts arrive via your preferred channel -- email, Slack, webhook, or our dashboard. Filter by signal type, score threshold, device category, or geographic market.
Key Benefits
What our customers gain from continuous regulatory monitoring
Know when competitors file 510(k)s, receive IVDR certificates, or enter new markets before it appears anywhere else.
Catch guideline changes, draft guidance, and policy shifts that affect your compliance strategy and submission timelines.
Monitor safety notices, recalls, and adverse events across your product portfolio and competitive landscape.
Start Monitoring Today
Choose the plan that fits your team and start receiving regulatory signals within 24 hours
See Plans & Pricing