PlatformComplaints

Complaint management software for medical device and pharma teams

Every complaint acknowledged on time, assessed for reportability by a named person, and answered. QMSdesk™ complaint management software for medical device and pharma teams runs each complaint from receipt to customer response on one signed workflow, and links it to the risk and CAPA it leads to.

Bring one workflow. See it running.See which workflows your profiles add

Complaints

CMP-004

Alarm failure reported on an infusion pump

Regulatory review

Workflow

Step 3 of 6: Regulatory review

Acknowledgement: Sent within 3 business days
Reportability: Signed decision with its reasoning
US MDR deadline: 30 days, set by the MDR profile

Calm, even when the complaint isn't

Acknowledged on time

Acknowledgment is tracked against a 3-business-day deadline from receipt. If it slips, it escalates to the right people before anyone has to notice.

Reportability decided, and signed

Whether a complaint is reportable is a regulatory question with a named answer. QMSdesk records that decision, and the reasoning behind it, with a signature.

The loop closes with the customer

A complaint isn't finished until the customer has heard back. The response is recorded on the complaint before it can close.

How medical device complaint management software should work

Step 1 of 6
Received
The complaint is logged with the customer, their contact and the product affected. The acknowledgment deadline starts.
Step 2 of 6
Investigation
The team investigates and records the root cause. The acknowledgment, with who it went to, is recorded here.
Step 3 of 6
Signed step
Regulatory review
A named reviewer decides whether the complaint is reportable, and records why.
Step 4 of 6
Signed step
CAPA decision
A separate signed decision on whether a CAPA is needed. When it is, the linked CAPA is raised in the same transaction.
Step 5 of 6
Customer response
What you told the customer, and when.
Step 6 of 6
Signed step
Closed
The closure is signed, and the closure-record PDF is ready.

Reportability and CAPA are separate decisions because they often rest on different considerations, and often on different reviewers.

Complaint handling for ISO 13485 §8.2.2 and medical devices

Since February 2, 2026, the FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference, so a device complaint is an ISO 13485 §8.2.2 record. QMSdesk is built to support organizations working to ISO 13485:2016.

With the MDR profile, QMSdesk adds what a device manufacturer needs around the complaint:

Vigilance on the complaint workflow, so a reportable device complaint follows the same signed path
Reporting deadlines set by the profile: 30 days for a US MDR report and 15 days for an EU serious incident
Post-market surveillance events, and UDI and serial number on nonconformances
The PRRC role, and retention for the device lifetime plus 15 years, with 15 years as the enforced minimum

Pharma complaint handling under GMP

With the GMP profile, complaints keep the 3-business-day acknowledgment, and product recalls run on the same signed complaint workflow. The QP, QC Head and Batch Release Specialist roles are in place, and records follow a 10-year retention floor.

What makes the record hold up

Complaint to risk to CAPA

A complaint links to the risks it raises and to the CAPA that follows. The CAPA comes from a signed decision, and every link between complaint, risk and CAPA is typed and attributed.

A closure record for every complaint

Once closed, the closure-record PDF lists every signature on the complaint: who signed, when, what it meant and why. Every download is logged.

Patterns across products

Event trending shows complaints by type, severity, site, product and root cause, so a problem that spans many complaints can become one CAPA.

Feature index

Everything in complaint management

The complaint workflow

Received, then Investigation, then Regulatory review, then CAPA decision, then Customer response, then Closed
Acknowledgment tracked against a 3-business-day deadline, with escalation on breach
Signed regulatory-reportability review, with justification
Separate signed CAPA decision, with the linked CAPA raised in the same transaction
Customer response recorded before closure
Signed closure and closure-record PDF

Added by regulatory profiles

MDR: vigilance on the complaint workflow, 30-day US MDR and 15-day EU serious-incident deadlines, post-market surveillance events, PRRC role
GMP: product recall on the complaint workflow, QP and Batch Release Specialist roles

Controls on every complaint

Anyone can log a complaint
Cancelled with a signed reason, never deleted
Deadlines that escalate but never block, with delay reasons
Typed, attributed links to risks, CAPAs and other records
Configurable numbering, never reissued
Recorded in the SHA-256 hash-chained audit trail

Oversight

My Work and the review queue
Event trending by type, severity, site, product and root cause

One connected system

Connected across QMSdesk

A complaint is one of the quality events QMSdesk handles.

A signed CAPA decision raises the CAPA, with its own change and training.

Complaints link to the risks they raise in risk management.

Regulations

Regulations it's designed to support

ISO 13485:2016 §8.2.2 (complaint handling). QMSdesk is built to support organizations working to it
The FDA QMSR and EU MDR, under the MDR profile
21 CFR Parts 210 and 211 and EU GMP, under the GMP profile, with Annex 11 record controls
21 CFR Part 11 for every signed decision

Questions buyers ask

Does QMSdesk file MDR or vigilance reports?

QMSdesk records the signed reportability decision and its reasoning, and the MDR profile sets the reporting deadlines: 30 days for a US MDR report, 15 for an EU serious incident. The report itself goes to the authority through its own channel.

Is acknowledgment a separate step?

No. It's a tracked obligation, not a stage. The 3-business-day deadline runs from receipt and escalates on breach, and the acknowledgment is recorded during the investigation.

Does every complaint need a CAPA?

Every complaint needs a signed CAPA decision. When the answer is yes, the linked CAPA is raised in the same transaction. When it's no, the justification is on the record.

Can we handle pharma and device complaints in one system?

Yes. Hold the GMP and MDR profiles together, and you get the workflows and roles of both, with the tightest deadline and longest retention floor winning.

Every complaint answered, and every answer on the record

Bring a complaint you handled recently, and we'll run it through QMSdesk with you.