Medical Device Complaint Handling Procedure Bundle

The Medical Device Complaint Handling Procedure Bundle groups six QMS procedures together. The complaint handling procedure relates to receiving, investigating, and complaint closure. The complaint trending procedure establishes methods of analyzing complaint data. The remedial action procedure governs product recalls of violative products. The MDR procedure describes the process of reporting events to the FDA. The vigilance procedure establishes the process for reporting incidents in the EU. The product hold procedure governs placing products on hold pending further investigation. The medical device complaint handling procedure bundle can establish or augment your complaint handling system as part of your ISO 13485, MDR 2017/745, and FDA QSR compliance goals.