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USFDA Medical Devices QS Regulations Harmonization

USFDA Medical Devices QS Regulations harmonization with ISO 13485 standard The US Food and Drug Administration (FDA) has published the long-anticipated final rule on Quality Management System Regulation (QMSR), aligning its requirements with the widely recognized International Organization for Standardization (ISO) standard. The move aims to establish consistency in regulatory expectations for device manufacturers across

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