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Part of Lead Intelligence · From €299/mo

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.

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Signal Types

18 signal types across 24 global data sources, classified and scored in real time

Regulatory Clearances

FDA 510(k), PMA, De Novo. IVDR, MDR, NMPA registrations.

Clinical Trials

New starts, phase changes, results, and completions across registries.

Patent Activity

Filings, grants, and expirations across USPTO, EPO, WIPO.

Funding Events

Series A-IPO, grants, and public market disclosures.

Safety Notices

Recalls, field safety actions, and adverse event reports.

Guideline Changes

Guidance updates, draft guidance, and policy shifts.

Sources: FDA, EUDAMED, EU CTIS, NMPA, PMDA, MFDS, TGA, ANVISA, WIPO, USPTO, EPO, ClinicalTrials.gov, and more.

How It Works

From raw data to actionable intelligence in minutes

1

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.

2

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.

3

Enrichment

Signals are enriched with company profiles, device classifications, patent links, and historical context. Raw regulatory text becomes structured, searchable intelligence.

4

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

Early
Competitive Intelligence

Know when competitors file 510(k)s, receive IVDR certificates, or enter new markets before it appears anywhere else.

Real-time
Regulatory Change Detection

Catch guideline changes, draft guidance, and policy shifts that affect your compliance strategy and submission timelines.

Continuous
Compliance Tracking

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

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