Taking a reactive, unstructured approach to complaint handling is a risky practice. Today’s quality and regulatory environment requires a compliance-driven complaint management practice that enables medical device manufacturers to:
- Implement a closed-loop complaint handling process
- Analyze trends, metrics and KPIs for process and product improvement
- Eliminate practices that can derail the effectiveness of a complaint management system
- Identify and evaluate valid complaints and determine which are not
- Conduct systematic, data-driven evaluations, investigations and regulatory reporting
- Relate complaint evaluation risk controls and premarket risk evaluations for true product lifecycle insight
- Achieve compliance with FDA device surveillance inspections
Learn strategies for implementing a complaint management process that facilitates gathering, evaluating, investigating and remediating complaints from the premarket stage to closure–and what practices to avoid.
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