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.
The Cost of Overlooking Usability: Why Medical Device Companies Can’t Afford to Get Human Factors Wrong in 2026
From 2020–2024, FDA oversaw nearly 4,000 device recalls — and device design is the #1 recall category. The hidden cost? Skipping formative usability testing and treating IEC 62366-1 as a checkbox. Here’s what it actually costs you.
The $5 Billion Opportunity: How Requirements Traceability Transforms Medical Device Success
1,059 recalls in 2024. $5B annual cost. The root cause? Broken requirements traceability. Discover the golden thread that connects user needs to design, risk management, and post-market surveillance.