Medical Device Regulatory Excellence

Complaint Handling & Global Reporting

Ensure Compliance. Mitigate Risk. Master Global Vigilance.

In the medical device industry, complaint handling is a critical regulatory function. Poor documentation or failure to report adverse events can lead to FDA Warning Letters, ISO non-conformities, and legal risk.

This training, led by Joe Azery (Aztech Regulatory and Quality), provides a practical framework to manage customer feedback and meet reporting obligations across US, EU, and MDSAP markets.

Program Overview

Module 1: Complaint Management

• ISO 13485 & FDA 21 CFR Part 820 alignment

• Complaint intake and documentation

• Root cause analysis and corrective actions

• Audit-ready record keeping

Module 2: Global Vigilance

• Complaint vs. reportable event decision logic

• US FDA MDR requirements

• EU, Canada, Australia, Brazil reporting

• Distributor and global coordination

Who It’s For

QA, RA, Customer Service, and Management teams.

Scale your compliance. Secure your market. Get started today.