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Analysis: Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices.

PMID: 32442013 · 2020

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ZeitschriftBiomedical instrumentation & technology

Jahr2020

PMID32442013

Zusammenfassung

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

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