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Home » Devicemakers Urged to Engage With FDA Over Proposed QMSR
Devicemakers Urged to Engage With FDA Over Proposed QMSR
Devicemakers need to be prepared to comment as the FDA rolls out guidance related to the incorporation of ISO 13485:2016 into the FDA’s proposed Quality Management System Regulation (QMSR), said a former senior agency official at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C.