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Administration Of Drug Software In Usa Pennsylvania

1 software items found
RegScan - Version MDR - Medical Device Reporting System

RegScan - Version MDR - Medical Device Reporting System

by:RegScan - by Enhesa   based inWilliamsport, PENNSYLVANIA (USA)
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and occasionally to both. These requirements are supplemental to ...
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