Home » FDA’s Proposed Quality System Rule Offers New Definitions, More Exact Requirements
FDA’s Proposed Quality System Rule Offers New Definitions, More Exact Requirements
November 4, 2022
Changes in definitions and more specific requirements are the hallmarks of the FDA’s proposal to bring its Quality System Regulation (QSR) more in line with the international standard ISO 13485, but the overall principles of the QSR remain, says one regulatory expert.
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