Articles by Bill Enos

Robotic surgery system positioned over an operating table in a surgical suite.
Management

From Transition to Compliance: Navigating QMSR Implementation and Inspection Readiness

Under the QMSR, the FDA is looking not merely at whether individual procedures exist, but whether the overall quality system is capable of consistently producing safe and effective devices.
Bill Enos
Bill Enos
July 26, 2026

With February 2026 now behind us, the FDA’s Quality Management System Regulation (QMSR) is here. For medical device manufacturers, the question has shifted from “are we ready?” to “can we demonstrate it?”


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