Complaint management software that decides MDR reportability — and proves it.
Every complaint in V5 is triaged against your MDR/MDV decision tree, linked to the lot and DHR, routed for investigation, and closed only when CAPA effectiveness is verified. The reportability decision — and the rationale — is captured on every record, exportable to FDA or Competent Authority on demand.
What breaks without this.
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.
Records-by-execution. Compliance, by design.
Single intake — web, email, phone, portal
Every channel lands in the same triage queue with SLA timers from the moment of receipt.
MDR / MDV decision tree on the record
Structured questions, branching logic, and the rationale captured at every step. Reviewers reach the same answer because the questions are the same.
Lot, DHR and design-record linkage
One click takes the investigator from the complaint to the manufacturing record, the operator, the supplier lot and the design history.
Auto-routing to CAPA when criteria fire
Trend triggers, severity triggers and reportability triggers all open CAPAs with the complaint pre-linked.
Regulator-ready exports
FDA eMDR, EU MIR, Health Canada — V5 holds the data; the export is a click, not a project.
What to look for when you're buying.
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
What it tests: Is the reportability decision made against a structured, versioned tree, with rationale captured?
Why it matters: FDA and Competent Authorities audit the decision, not just the report.
V5: Every complaint runs through the current MDR/EU MDR tree; the rationale is a required field before closure.
Lot / DHR / UDI linkage
What it tests: Is the complaint linked to the specific lot, DHR and UDI at intake?
Why it matters: Investigations without device linkage cannot pass §820.198.
V5: UDI-first intake pre-links DHR and lot; investigation opens with the device history in view.
Timeliness clock
What it tests: Does the system track the regulatory clock (24h, 5d, 15d, 30d) with escalation?
Why it matters: Missed deadlines are the observation, regardless of investigation quality.
V5: Clocks start at intake; escalation and executive alerts fire before the deadline.
CAPA linkage with effectiveness gate
What it tests: Does closure require CAPA effectiveness when required?
Why it matters: A closed complaint without effectiveness verification is a repeat waiting to happen.
V5: Complaints requiring CAPA cannot close without linked effectiveness verification.
Trend for post-market surveillance
What it tests: Are complaints trended by device, indication, failure mode and severity?
Why it matters: MDR Article 83-86 PMS is trend-driven, not case-by-case.
V5: Live trend feeds PMS report drafts; unusual signals raise alerts.
Regulator export format
What it tests: Does the system export in the exact formats FDA and CAs consume?
Why it matters: Manual rebuilds miss deadlines.
V5: eMDR (FDA), EUDAMED-ready payloads and CA templates supported.
Spreadsheet vs legacy QMS vs V5.
How V5 complaint handling compares to spreadsheet trackers and legacy complaint modules.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| 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 |
| eMDR export | Manual re-key | Extra module | In-box |
The clauses, verbatim — and how V5 answers each.
Complaint handling is a top-three FDA inspection topic. Below are the clauses and V5's answer.
Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints...
V5: Intake, review, investigation, closure and reportability are one lifecycle on one record set.
You must submit an initial report to FDA no later than 30 calendar days after the day you become aware...
V5: The clock starts at intake; escalation fires days before deadline; eMDR is one-click.
Manufacturers of devices... shall report... any serious incident... immediately after they have established a causal relationship...
V5: Causality is a required field with rationale; timeliness clocks are Article-87 aware.
The organization shall document procedures for a timely complaint handling process...
V5: Timeliness is enforced by the system, not by memory.
Step by step on the floor.
V5 handles a complaint from the first call to the eMDR submission — on one record.
- 1Intake
UDI-first capture
Complaint opened with UDI; DHR, lot and prior complaints for the device presented.
- 2Triage
Reportability decided
Structured tree run; rationale captured; clock starts.
- 3Investigate
Root cause and impact
Investigation record linked; CAPA raised if warranted.
- 4Report
eMDR / vigilance filed
Regulator export generated and submitted from the same record.
- 5Close
Effectiveness verified
Closure gated on CAPA effectiveness when applicable.
- 6PMS
Trending feeds PSUR / PMS
Signals fed to periodic reports and to design-controls risk feedback loops.
The math, with the assumptions visible.
Complaint ROI is dominated by missed-deadline avoidance and PMS labour.
Missed 30-day MDR
Escalation before deadline plus in-system eMDR.
PMS report labour
Live trend and derived draft.
Repeat complaints
CAPA effectiveness gate closes the failure mode.
PMS labour and avoided late-MDR risk typically fund the module inside a year.
What changed on the floor.
Setting
A Class II device manufacturer scaling from 400 to 1400 complaints/year.
Before
Spreadsheet triage; missed one 30-day MDR in a prior year; PMS reports built manually across three devices for 6 weeks each.
After
Zero missed MDR clocks post-cutover; PMS reports derived in under 4 days; repeat-complaint rate on the top failure mode reduced 46% after CAPA effectiveness enforcement.
Proof points
- MDR clock starts the moment the complaint is received — not when QA finds out
- Reportability decision tree captured on every record
- Trend triggers escalate to CAPA automatically
- eMDR / MIR exports in minutes
Built to satisfy
- 21 CFR 820.198 (complaint files — medical devices)
- 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)
Related on V5
Frequently asked questions
Does V5 handle MDR reportability decisioning?+
Yes — the §803 decision tree is built in, the rationale is captured on the record, and eMDR-ready exports are one click. EU MIR and Health Canada formats are also supported.
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.
How fast can we deploy?+
Complaints is part of the V5 Quality module — live in 7 days with standard onboarding, including migration of open complaint files.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.