RegIntel 360 · Professional Intelligence

Daily FDA Intelligence, Curated.

The complete regulatory intelligence platform for medical device professionals who need to stay ahead of every FDA action, EU MDR change, and enforcement trend.

Subscribe at $299/month

Cancel anytime. No long-term contracts.

What's included in RegIntel 360

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Daily FDA Briefing

Every morning, get a curated summary of FDA actions that matter to your submissions: 510(k) clearances, warning letters, guidance documents, and enforcement updates.

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Warning Letters Monitoring

Real-time tracking of FDA warning letters across all device classifications. Understand enforcement trends before they reach your product category.

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Guidance Document Updates

Never miss a draft or final guidance. We track every FDA guidance document relevant to medical devices, with plain-English summaries of what changed.

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EU MDR Tracking

Stay current on EU MDR implementation timelines, EUDAMED updates, notified body capacity changes, and harmonized standard revisions.

Everything you need to stay compliant

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Daily intelligence briefings
Delivered to your inbox every weekday morning before 8 AM ET
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Searchable archive
Full-text search across all past briefings and regulatory actions
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510(k) decision tracking
Monitor clearances, SE determinations, and NSE letters by product code
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PMA supplement alerts
Track PMA approvals and supplement decisions for competitive intelligence
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Recall and MDR signal monitoring
Early warning on recalls and adverse event trends in your device category
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MDSAP audit intelligence
Cross-jurisdiction regulatory updates across FDA, Health Canada, TGA, ANVISA, and PMDA

RegIntel 360

$299/month

Full access to daily FDA intelligence

Subscribe at $299/month