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.
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.