“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices
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 dissatisfaction
- Usability issues
- Distributor observations
- Technical support interactions
- Returned products
- Any information suggesting the device may not meet requirements
Complaints Are Often Hidden
Potential complaint signals can be found in:
- Customer emails
- Distributor communications
- Service reports
- Sales team discussions
- Training sessions
- Social media comments
- Technical support tickets
If these sources are ignored, valuable post-market information is lost.
Why Zero Complaints Can Be a Red Flag
Imagine a company with:
- 5,000 devices on the market
- Products sold in 20 countries
- Daily clinical use
And yet…
- No complaints
- No usability observations
- No customer questions
- No returned devices
Experienced auditors may not celebrate.
Instead, they may question whether the complaint handling process is effective enough to capture real-world information.
Complaint Handling Impacts the Entire Quality System
Weak complaint collection doesn’t only affect one procedure.
It directly influences:
- Clinical Evaluation Reports (CER)
- Post-Market Surveillance (PMS)
- PMCF activities
- PSUR preparation
- Benefit-Risk assessments
- State-of-the-art reviews
If complaint data is incomplete, clinical evidence may also be incomplete.
Five Practical Recommendations
- Define complaints broadly.
- Review every customer-facing information source.
- Create a structured complaint screening process.
- Trend data regularly to identify recurring issues.
- Periodically challenge your system by asking:
“Would an auditor agree that we’ve identified every potential complaint?”
Final Thought
The next time someone proudly says,
“We’ve never had a complaint,”
don’t celebrate immediately.
Ask instead,
“How do we know?”
Because in medical devices, the absence of complaints is not always evidence that everything is working perfectly.
Sometimes, it’s evidence that nobody is looking.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
