Complaint Handling Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints.

• Comprehensive Complaint Data Capture Form

• Includes Decision Trees (FDA MDR, Canadian, European)

• MS Word Format

• Digital Content - Instant Download

Complaint Handling Procedure

The Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting, and closing medical device complaints.

Complaint Handling Procedure - Overview

The ISO 13485:2016 Complaint Handling Procedure provides instruction on sources of complaints, how to receive complaints into the system, required complaint information, complaint investigations, complaint closure and the establishment of complaint files. The Complaint Handling Procedure includes complaint reporting decision trees. The Complaint Handling Procedure includes FDA MDR, Vigilance, and Canadian reporting decision trees.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.