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

In this Complaint Management primer webcast you will 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.

Taking a reactive, unstructured approach to complaint handling is a risky practice. Today’s quality and regulatory environment require a compliance-driven complaint management practice that enables medical device manufacturers to:

Key focus areas include:

  • 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 pre-market risk evaluations for true product lifecycle insight
  • Achieve compliance with FDA device surveillance inspections

Download the AssurX Complaint Management Brochure

Streamline the complaint lifecycle from intake through investigation, root cause analysis, corrective action, and regulatory reporting throughout the product lifecycle.

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