FDA Inspection Delays And The ISO 13485 Imperative: Why Medical Device Manufacturers Can’t Wait
The FDA’s inspection strategy became more targeted, more data-driven, and more unforgiving of systemic compliance gaps in 2025, even as the agency faced unprecedented operational challenges due partially to a government shutdown. In fact, a critical deadline arrived recently for medical device manufacturers this February. The FDA’s new Quality Management System Regulation (QMSR) is now … FDA Inspection Delays and the ISO 13485 Imperative: Why Medical Device Manufacturers Can’t Wait