Complaints · MDR · Vigilance
Complaint management that keeps reportability decisions documented.
Capture each complaint, link it to the lot and investigation, and record who decided whether it was reportable and why.
Every Complaint Linked
Each complaint sits with the lot, the investigation and any CAPA.
Decisions Documented
Your team records whether it is reportable, who decided and why.
Patterns Surfaced
AI can group similar complaints for a reviewer to check.
What goes wrong today3 common problems
Complaints Sit in Inboxes
Customer service logs an issue, QA hears about it three weeks later, the MDR clock has already started.
Reportability gets decided on gut feel
Without a structured decision tree captured on the record, two reviewers reach different conclusions on the same complaint.
No Line of Sight to the Lot
If the complaint can't be traced to the batch, the operator, the supplier and the design history, the investigation is a guess.
How it works, step by step6 steps
- UDI-First Capture. Complaint opened with UDI; DHR, lot and prior complaints for the device presented.
- Reportability Decided. Structured tree run; rationale captured; clock starts.
- Root Cause and Impact. Investigation record linked; CAPA raised if warranted.
- Effectiveness Verified. Closure gated on CAPA effectiveness when applicable.
- Trending Feeds PSUR / PMS. Signals fed to periodic reports and to design-controls risk feedback loops.
What to look for when choosing
Complaint systems live or die on the reportability decision. If you cannot show — for every complaint — who decided, on what evidence and by what tree, you have a filing cabinet, not a complaint system.
MDR / Vigilance Decision Tree
Is the reportability decision made against a structured, versioned tree, with rationale captured? Every complaint runs through the current MDR/EU MDR tree; the rationale is a required field before closure.
Lot / DHR / UDI Linkage
Is the complaint linked to the specific lot, DHR and UDI at intake? UDI-first intake pre-links DHR and lot; investigation opens with the device history in view.
Timeliness Clock
Does the system track the regulatory clock (24h, 5d, 15d, 30d) with escalation? Clocks start at intake; escalation and executive alerts fire before the deadline.
CAPA Linkage with Effectiveness Gate
Does closure require CAPA effectiveness when required? Complaints requiring CAPA cannot close without linked effectiveness verification.
Trend for Post-Market Surveillance
Are complaints trended by device, indication, failure mode and severity? Live trend feeds PMS report drafts; unusual signals raise alerts.
Regulator Export Format
Does the system export in the exact formats FDA and CAs consume?
V5 Compared with Other Approaches
How V5 complaint handling compares to spreadsheet trackers and legacy complaint modules.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Reportability decision tree | None | Static form | Versioned tree with rationale capture |
| UDI/lot pre-link at intake | Manual | Sometimes | UDI-first intake with DHR context |
| Regulatory clock | None | Optional | Native with escalation |
| CAPA effectiveness gate | None | Configurable | Mandatory when required |
| Manual re-key | Extra module | In-box |
Regulations this supportsYour quality team stays responsible for compliance
Complaint handling is a top-three FDA inspection topic. Below are the clauses and V5's answer.
EU MDR Article 87
Causality is a required field with rationale; timeliness clocks are Article-87 aware.
ISO 13485 §8.2.2
Timeliness is enforced by the system, not by memory.
Standards Referenced
- 21 CFR 803 (MDR — medical device reporting)
- EU MDR Article 87 (reporting of serious incidents)
- ISO 13485 §8.2.2 (complaint handling)
- 21 CFR Part 11 (electronic records & signatures)
Common questions2 answers
- Can complaints come from multiple channels?
- Yes — web form, customer email, phone-logged, partner portal, and direct API from your CRM or service-desk tool. All land in the same triage queue.
- When does a complaint open a CAPA?
- On severity, trend or reportability triggers you define — and any reviewer can open one manually. The complaint is always pre-linked.