The Hidden Cost of Technical Debt in Medical Device Development
Every engineering team under schedule pressure makes tradeoffs. Document it later. Close the risk gap after the milestone. Patch the test protocol after verification. These decisions accumulate quietly—until a 510(k) rejection, an FDA inspection, or a post-market complaint forces a reckoning that costs orders of magnitude more than the original shortcut.
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.

