The Intelligence Center.
Data-driven insights on the regulatory landscape. From the 2027 EU MDR Cliff to daily recall patterns.
Whitepaper: The 2027 Extinction Event.
Why 30% of legacy devices will vanish from the EU market in 2027—and how to ensure yours isn't one of them.
Live Recall Patterns (2025-2026)
Software Labeling Errors up 200%
Insight: AI-generated code requires human validation.
Sterile Barrier Breaches
Insight: New ISO 11607 standards are catching legacy packaging.
FDA Refuse-to-Accept (RTA) Spike
Insight: Missing SBOMs are the #1 cause of rejection this quarter.
Predicate Device Search
Find your 510(k) predicate in seconds, not hours. Search by Code, Regulation, or Description.
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