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Home » QMSR to Incorporate ISO 13485, FDA ‘Satellite’ Rules by Reference, Expert Explains
QMSR to Incorporate ISO 13485, FDA ‘Satellite’ Rules by Reference, Expert Explains
Understanding FDA quality system requirements may be more confusing under the new Quality Management System Regulation (QMSR) due to be finalized in December, says one regulatory expert, but actual compliance will be less cumbersome when U.S. and international expectations are aligned.