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Information Seminar Paper

Title

RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER

Pages

 Start Page | End Page

Abstract

 IVD MEDICAL DEVICE MANUFACTURERS ARE GENERALLY REQUIRED TO HAVE A QUALITY MANAGEMENT SYSTEM AS WELL AS PROCESSES FOR ADDRESSING DEVICE RELATED RISKS. THE IVD MANUFACTURER SHALL ESTABLISH, DOCUMENT AND MAINTAIN THROUGHOUT THE LIFE-CYCLE AN ONGOING PROCESS FOR IDENTIFYING HAZARDS ASSOCIATED WITH AN IVD MEDICAL DEVICE, ESTIMATING AND EVALUATING THE ASSOCIATED RISKS, CONTROLLING THESE RISKS, AND MONITORING THE EFFECTIVENESS OF THE CONTROLS...

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