Turning Medical Device Complaints into Quality Insights eBook

Definitive Guide to Complaint Handling


The need to define, document, or implement a complaint-handling system and failure to follow up on complaints about medical devices are among the most frequently cited observations on FDA-483s.

This eBook explains how companies that have reliable quality processes, systems and reporting infrastructures in place are able to facilitate effective and timely complaint management, which includes tracking and reporting adverse events, UDI and eMDR system mandate.
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