A Complaint Management Primer: Compliance-Driven Strategies for Effective Complaint Management

"Medical device complaint handling and adverse event reporting has been required since the first iterations of ISO 13485 and FDA guidance for quality systems. Yet, complaint management practices continue to be the top reasons for FDA 483 observations and warning letters. Taking a reactive, unstructured approach to complaint handling is a risky practice. That is why implementing a compliance-driven complaint management process is critical for medical device manufacturers to:

• Create an organizational process for recognizing and reporting complaints inside and outside of standard channels
• Rapidly identify and evaluate complaints that are valid and determine which are not
• Conduct systematic, data-driven evaluations, investigations and regulatory reporting
• Gain enterprise-wide visibility into complaint data to track with performance metrics, dashboards and other indicators
• Associate complaint evaluation risk control with premarket risk evaluations for true product lifecycle insight
• Achieve compliance with FDA device surveillance inspections

This webinar will discuss 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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