Skip to main content

​
Summary

Complaints establishes your systematic approach to customer feedback management by documenting and tracking all device-related complaints and negative product events. You implement structured complaint handling through the Complaint Log which serves as your central repository for complaint management, enabling regulatory compliance, trend analysis, and quality improvement activities throughout your post-market surveillance system.

​
Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation):
  • Complaint files required under Section 820.198 for all device-related complaints
  • Must maintain records of oral and written complaints involving device failures
  • Investigation and evaluation of complaints affecting device safety required
  • Medical Device Reports (MDRs) under 21 CFR 803 for serious complaint-related incidents
  • Trend analysis required to identify systematic quality problems
Special attention required for:
  • Class III devices requiring enhanced complaint investigation procedures
  • Software malfunctions that could affect patient safety or device effectiveness
  • Repeat complaints indicating systematic quality issues requiring CAPA
  • Use errors potentially related to design or labeling deficiencies

​
Overview

Complaints provides the foundation for customer feedback management by establishing systematic processes to capture, evaluate, and respond to all device-related concerns that could impact safety, performance, or regulatory compliance. This card ensures that customer communications alleging deficiencies in device quality, reliability, safety, effectiveness, or performance receive appropriate documentation, investigation, and resolution through your quality management system. The Complaint Log serves as your central repository for tracking all complaints and negative product events while distinguishing them from general customer support inquiries that don’t relate to device performance issues. This systematic documentation enables regulatory compliance by maintaining the comprehensive complaint files required under FDA QSR and EU MDR, while supporting post-market surveillance activities through trend analysis and pattern identification that can reveal emerging safety concerns or systematic quality issues. The complaint management process provides early warning signals for potential safety issues by capturing real-world user experiences that may indicate design deficiencies, manufacturing problems, or labeling inadequacies. Unlike controlled clinical environments, complaints reveal how devices perform in diverse real-world conditions with varied user populations and use environments. This feedback enables proactive identification of issues before they escalate into serious incidents or widespread safety concerns. Complaint categorization and routing ensures that different types of issues receive appropriate resolution processes based on their impact on device performance and safety. Software issues follow Software Problem Resolution procedures with systematic debugging and verification, product compliance issues trigger Corrective and Preventive Action (CAPA) investigations for root cause analysis, and design changes follow Change Management processes with proper impact assessment and regulatory evaluation. The systematic approach to complaint handling integrates seamlessly with your vigilance system for incident assessment, post-market surveillance for trend analysis, risk management for hazard evaluation, and clinical evaluation for real-world performance validation. This integration ensures that customer feedback contributes to continuous improvement while maintaining the audit trail and documentation standards required for regulatory compliance. Effective complaint management demonstrates your commitment to customer safety and quality improvement by showing that you systematically monitor user experiences, respond appropriately to concerns, and implement preventive measures to avoid recurrence. This systematic approach protects patients through early problem identification, maintains regulatory compliance through comprehensive documentation, and builds stakeholder confidence through responsive customer service and continuous product improvement.