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FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR
February 3, 2026
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Source: Management Systems World
The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.
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