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Quality & Compliance

Complaint Management.

Using complaints as a quality tool. We help medtech and pharmaceutical companies establish a comprehensive complaint management system—in compliance with ISO 13485 and the MDR.

Quality team at the complaint review meeting

How do medtech and pharmaceutical companies manage customer complaints in a way that is compliant with regulations and leaves no gaps?

ISO 13485 and the MDR require a systematic complaints management process. Without well-defined processes, significant compliance risks arise:

  • Complaints that are not recorded or are filed without being evaluated constitute serious inspection findings.
  • The lack of a trend analysis of complaint frequencies prevents the identification of systematic product defects.
  • There is no clearly defined process for determining whether a complaint must be reported (pharmacovigilance).
  • Complaints are not used as a PMS database—valuable information from the field goes to waste.
Does your company fully record, assess, and systematically analyze all incoming customer complaints?
A quality specialist fills out a complaint resolution form

Our complaint management services.

We build structured complaint systems that are compliant with regulations and easy to manage.

Complaint System Design & Process Development
Complete complaint management process in accordance with ISO 13485 Section 8.2.2 and the MDR: intake, evaluation, investigation, CAPA implementation, vigilance review, and closure, including SOPs that comply with the standards.
Pharmacovigilance Linkage & Reporting
Seamless integration with the vigilance system: structured assessment of each complaint regarding reporting requirements (MDR Article 87), clear escalation rules, and documentation of the reporting decision.
Complaint Trends & Signal Detection
Establishing a systematic complaint tracking system: frequency analyses, risk prioritization, and correlation with PMS data to enable early detection of genuine product issues.
Resolution of the Complaint Backlog
Structured processing of open and incompletely documented complaints. Prioritization based on pharmacovigilance relevance and inspection risk, followed by formal closure.

Real-world examples: Reducing the complaint backlog and MDR readiness.

A medical device manufacturer (Class IIb) was about to undergo an MDR audit and had hundreds of unresolved customer complaints in its system.

The challenge

Critical backlog without a vigilance assessment.

More than 400 unresolved complaints from the past two years had accumulated in the system. None of these cases were systematically reviewed for mandatory reporting requirements (pharmacovigilance) or formally closed with an investigation.

Measures

Triage, Assessment & Task Force.

Entourage established a QA task force to conduct immediate triage. Each complaint was systematically reviewed for patient safety risks and vigilance relevance. Similar complaints were grouped together for trend analysis.

Results

Audit passed, backlog resolved.

Within six weeks, the entire backlog was systematically assessed and streamlined. The subsequent audit revealed no critical findings; the auditor explicitly praised the new trending concept.

Why Choose Entourage for Your Complaint Management.

Complaints are more than just a necessary evil—they are the most important source of systematic product improvements.

Pharmacovigilance & PMS Expertise.

We do not treat complaints in isolation. We ensure that your complaint data is seamlessly integrated into post-market surveillance (PMCF/PSUR) and regulatory safety reporting.

Operational relief (hands-on).

If the system becomes overwhelmed, we step in to take over. Our experts provide direct support with case handling, technical troubleshooting, and communication with government agencies.

Regulatory depth of field.

We are familiar with the exact requirements of the FDA, ISO 13485, and the MDR regarding the complaint file. Each of our process SOPs is designed for direct use during audits.

Seamless CAPA integration.

A complaint without corrective action is useless. We structure your processes so that effective corrective actions (CAPAs) are automatically derived from critical complaints.

This is how we work.

The structured 4-step process for legally compliant complaint handling.

01

Intake & Triage.

Systematic recording of complaints within 24 hours and immediate assessment of potential patient risk, as well as compliance with legal reporting requirements.

02

Investigation.

Systematic investigation of the cause of the defect in the product and comparison with the assumptions in the existing risk management records.

03

CAPA & Vigilance.

Identification of necessary corrective actions (CAPA) and, where applicable, timely reporting of the incident to the authorities.

04

Closure & Trends.

Formal closure of the complaint file and transfer of the case data to the regular quality trending process (PMS).

Frequently Asked Questions About Complaint Management.

What constitutes a complaint under ISO 13485?
According to ISO 13485, Section 3.4, a complaint is any written, verbal, or electronic communication indicating a nonconformity of a medical device with respect to its identity, quality, durability, reliability, functional safety, or performance—including labeling and instructions for use.
Do all complaints have to be investigated?
Yes, every complaint must be evaluated at a minimum to determine: Is it justified? Does it require a physical product inspection, the initiation of a CAPA, or a vigilance report? Not every complaint necessarily leads to a months-long laboratory investigation, but the formal decision on this matter must be documented.
How are complaints and post-market surveillance related?
Complaint data is one of the most important sources of PMS data under the MDR. It is incorporated into PMS plans and PSUR/PMCF reports and can trigger changes to risk analyses or product design. Without a functioning complaint system, your PMS reports are effectively incomplete and worthless.
At what complaint rate must an FSCA be initiated?
There is no fixed threshold. The decision to initiate a Field Safety Corrective Action (recall) is based on the risk associated with the incident, the complaint rate relative to market volume, and the severity of the potential risk to patients. A structured trend analysis is key to establishing this case.

Additional expertise in the area of Quality & Compliance.

Expertise

CAPA Management

Effectively manage corrective and preventive actions and derive them from customer complaints.

 Expertise

Deviation Management

Record internal discrepancies in a legally compliant manner and streamline investigation processes.

 Expertise

Post-Market Surveillance

Systematically integrate adverse event data into PMS plans, PSURs, and PMCF reports.

Establish complaint processes that are audit-ready.

Whether you need to revamp your reporting system, provide vigilance training for your teams, or require immediate hands-on support to clear a backlog of complaints, we bring the necessary expertise directly to your company.

Submit a project inquiry.

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