Glossary Term
Complaint Handling Systems
Definition
A Complaint Handling System is a formalized process and set of tools used by MedTech companies to document, investigate, analyze, and resolve customer complaints related to medical devices. It ensures compliance with regulatory requirements and supports continuous quality improvement by identifying potential product issues and mitigating risks.
Relevance to the MedTech Industry
The Complaint Handling System plays a critical role in maintaining customer trust, ensuring patient safety, and demonstrating a company’s commitment to quality and compliance. It is a key component of a Quality Management System (QMS) and provides insights for improving products and processes.
Additional Information & Related Terms
Corrective and Preventive Action (CAPA) Actions triggered by complaints to address and prevent recurring issues.
Post-Market Surveillance Complaint handling is a key element of post-market monitoring and reporting.
Risk Management File Includes analysis of complaint trends to evaluate potential risks.
Adverse Event Reporting Complaints involving safety risks may require reporting to regulatory agencies.