How do you capture, assess and close customer complaints in a compliant and gap-free manner?
We build a complaint management system that captures, assesses and closes every incoming complaint with full documentation, in line with ISO 13485:2016 and the Medical Device Regulation (EU) 2017/745, integrated with vigilance, post-market surveillance and CAPA. The decisive weak point is rarely the individual complaint, but the missing linkage: anyone who fails to run intake, reportability assessment and trending as a single process chain overlooks the systematic product problem behind the individual cases, and that is exactly what an inspection finds first.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What do ISO 13485 and the MDR require from complaint management?
Complaint processes from intake to closing in line with ISO 13485:2016 clause 8.2.2 and MDR (EU 2017/745), integrated with vigilance, PMS and CAPA
Last updated: 2026-06-13
ISO 13485:2016 and the Medical Device Regulation (EU) 2017/745 require a systematic complaint management system that goes beyond customer service: every complaint must be captured, assessed, documented and closed with a traceable disposition. The recurring weaknesses where systems fail in audits and inspections:
- Complaints that are not captured or are filed without assessment. Clause 8.2.2 of ISO 13485:2016 requires a defined process for receipt, assessment and investigation of every complaint; an undocumented complaint is a direct audit and inspection finding.
- No process for assessing reportability. For every complaint it must be assessed whether a reportable serious incident under MDR Art. 87 is present; without a clear decision rule, this check remains unsubstantiated.
- No trend analysis across complaint frequencies. If complaints are only handled as individual cases, the systematic product problem that should trigger a field safety corrective action remains invisible.
- Complaints are not used as a PMS data source. Under MDR Art. 83–86, complaint data is one of the central inputs to post-market surveillance; if it is missing, the PMS plan, PSUR and PMCF evaluation are incomplete.
- Unclear definition of terms. Under clause 3.4 of ISO 13485:2016, a complaint is any written, oral or electronic communication alleging a deficiency in a product; without this clean delineation, reportable communications are misclassified as mere service requests.
Services
How we support you
Complaint system design & process setup
Building the complete complaint process in line with ISO 13485:2016 clause 8.2.2 and MDR requirements: intake, assessment, investigation, CAPA derivation, reportability assessment and closing. The deliverables are compliant SOPs and intake forms with defined responsibilities and deadlines.
Vigilance coupling & reporting
Integration of the complaint process with the vigilance system: a structured assessment of every complaint for reportability under MDR Art. 87 with a documented escalation rule. The deliverable is a decision path that makes the reporting decision for every complaint defensible.
Learn more →Complaint trending & early signal detection
Setting up systematic trending: frequency analyses, risk prioritization and correlation with PMS data under MDR Art. 83–86. The deliverable is a trending logic that identifies recurring product problems from data patterns instead of reacting to individual cases.
Learn more →Complaint backlog remediation
Structured processing of open and incompletely documented complaints, prioritized by reportability relevance and inspection risk. The deliverable is the closure of every complaint with complete investigation documentation and a traceable disposition.
PMS and CAPA integration
Integrating complaint data as an input into post-market surveillance under MDR Art. 83–86 and into the CAPA system. The deliverable is an end-to-end linkage that derives CAPAs and PMS evaluations traceably from confirmed complaints.
Learn more →How we work together
What it comes down to
A complaint management system rarely fails because of the individual complaint, but because of the order of assessment. Intake must be followed by the reportability check: whether a serious incident is present, the reporting of which is governed by MDR Art. 87, determines the deadline and the escalation before the actual product investigation even begins. Only then do investigation, CAPA derivation and closing take effect. Anyone who pushes this check to the end loses precisely the step that is under time pressure, and a late report carries more weight than the complaint that triggered it.
The second bottleneck is aggregation. A single, individually assessed complaint says little; only trending across frequencies makes visible the systematic product problem that should trigger a field action. It is precisely this aggregated complaint data that, under MDR Art. 83–86, is a central input to post-market surveillance. This is why we build the chain as a whole: a clean intake feeds the trending, the trending feeds PMS and CAPA, and the documented closure of every complaint keeps the backlog small, the backlog that in an inspection is otherwise the first visible evidence of a system that is not working.
Our approach
Our approach
Step
Result
As-is assessment & gap analysis
Comparison of the existing complaint handling against ISO 13485:2016 clause 8.2.2 and the MDR; a prioritized gap list ranked by inspection risk.
Process & SOP design
A defined complaint process with SOPs, forms, responsibilities and deadlines from intake to closing.
Vigilance & PMS integration
A documented reportability assessment under MDR Art. 87 and the connection of complaint data to PMS under MDR Art. 83–86.
Trending & CAPA derivation
Established trending for early signal detection and the traceable derivation of CAPAs from confirmed complaints.
Backlog remediation
Open complaints processed by priority and closed with complete investigation documentation.
Common pitfalls
Where projects commonly fail
Complaints are filed without assessment.
Clause 8.2.2 of ISO 13485:2016 requires that every complaint is assessed and investigated; a complaint closed without a documented disposition is a direct inspection finding and can hardly be substantiated after the fact.
The reportability check is missing or undocumented.
Without a clear decision rule as to whether a complaint is a serious incident under MDR Art. 87, the reporting decision remains unsubstantiated, and a late or omitted report carries more weight than the complaint itself.
There is no trending across complaint frequencies.
If complaints are handled only individually, the systematic product problem behind the individual cases is overlooked; this very pattern triggers a field safety corrective action.
Complaint data does not feed into post-market surveillance.
Under MDR Art. 83–86, complaints are a central PMS data source; if they are not fed in, the PMS plan, PSUR and PMCF evaluation are incomplete and stand out in the surveillance audit.
The complaint backlog grows unnoticed.
Open and incompletely documented complaints pile up because prioritization and deadlines are missing; in an inspection, the unprocessed backlog is the first visible evidence of a system that is not working.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR), primary text, Art. 83–86, 87
- ISO 13485:2016, Quality management systems for medical devices, clauses 3.4 and 8.2.2
- Writer source material: Complaint Management (Quality Management & Operational Excellence)
- https://theentourage.de/expertise/complaint-management/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Art. 87 (vigilance, reporting of serious incidents)
- MDR Art. 83–86 (post-market surveillance)
- ISO 13485:2016 (QM system for medical devices)
- ISO 13485:2016 clause 8.2.2 (complaint handling)
- ISO 13485:2016 clause 3.4 (definition of complaint)
Related topics
Medical Device Vigilance →
Reportability assessment of serious incidents under MDR Art. 87
Post-Market Surveillance →
Complaint data as a PMS data source under MDR Art. 83–86
CAPA Management →
Derivation of CAPAs from confirmed complaints
Quality Management →
Embedding the complaint process into the QM system under ISO 13485:2016
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