Medical Device Complaint Handling System
$149.00
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The medical device complaint handling system establishes the process for handling medical device complaints. The procedure applies to handling all complaints for medical devices manufactured and/or distributed by the company. Complaint decision trees guide if a complaint is a reportable event or incident. The procedure and related forms are written in MS Word and can be easily modified. The medical device complaint handling system complies with the quality system requirements of ISO 13485, FDA QSR, and MDR 2017/745.
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