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The FDA design control guidance discusses subjects in which they appear in the FDA’s Quality System Regulation. It is cross-referenced to International Organization for Standards (ISO) 9001:1994, Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and the ISO draft international standard ISO/DIS 13485, Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001, dated April 1996.

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