Author:
Liebel Teresita C.,Daugherty Tara,Kirsch Alexandra,Omar Sharifah A.,Feuerstein Tara
Abstract
Abstract
This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.
Publisher
Association for the Advancement of Medical Instrumentation (AAMI)
Subject
Computer Networks and Communications,Biomedical Engineering
Cited by
10 articles.
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