CSA in the Era of QMSR: How FDA’s New Regulation Redefines Assurance Expectations

Topic: CSA in the Era of QMSR: How FDA’s New Regulation Redefines Assurance Expectations

Description:

As FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026, medical device organizations face the most significant shift in quality and compliance expectations in decades. QMSR aligns U.S. requirements with ISO 13485:2016, embedding risk-based thinking, lifecycle oversight, and stronger quality management principles.