Medical Device Complaint Handling and Servicing


1 hour and 30 minutes

Course Overview

Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and corrective and preventive actions (CAPA). It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard.

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