The Hidden Cost of Technical Debt in Medical Device Development
Engineering expertise and regulatory accountability almost never sit in the same person. As of February 2, 2026, FDA’s new inspection framework follows risk across the full product lifecycle—and that gap is no longer a background risk. It is a current exposure.
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.