“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices

Medical Device made Easy Podcast · Jun 25, 2026

At first glance, hearing “We’ve never had a complaint” sounds like excellent news.

No customer dissatisfaction.

No product issues.

No safety concerns.

But for Quality and Regulatory professionals, this statement should trigger an entirely different question:

How do you know?

What Is a Complaint?

Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word “complaint.”

Regulators take a much broader view.

A complaint may include:

Unexpected device performance

Product malfunctions

Customer…