The Game Has Changed: Why FDA’s New Risk-Based Inspection Process Demands a Different Kind of Consultant
February 2, 2026: FDA’s new inspection manual made checklist inspections obsolete overnight. Now investigators follow risk through interconnected processes—and if your QMS can’t demonstrate bidirectional traceability in real-time, you’re not ready.
Own Your Device’s Entire Journey: Why Smart Companies Treat Complaints as Strategic Assets
Complaint handling ranked 3rd in FDA warning letter citations in FY2025. With QMSR now in effect, one complaint can trigger MDR evaluation, CAPA, design reviews, risk updates, and multi-stakeholder notifications. Here’s how to stop firefighting and start leading.