The Five-Day Clock

A surgeon reports that a device shut off during a procedure. Monday morning, 9:47 AM. The call goes to customer service. The rep logs it in the system—"device turned off during use"—and assigns it to the complaint queue. The person who normally triages complaints is on vacation Tuesday. Nobody reviews it until Wednesday afternoon. Thursday morning, someone finally reads the notes carefully and realizes: device malfunction during a surgical procedure. This might be reportable.

The clock started Monday at 9:47 AM. You have five calendar days to report if this involved death or serious injury. It's now Thursday. You've used almost four days to figure out that you have a reporting window. One day left to investigate, determine reportability, complete the MDR form, obtain required signatures, and submit to FDA.

This is the complaint handling nightmare. Not the investigation—that's hard but manageable. The nightmare is the triage delay that eats your reporting window before you know you need it.

Finding the Signal in the Noise

Every complaint handling system faces the same fundamental challenge: most complaints are noise, but the signals are buried in that noise and have regulatory deadlines.

Ninety-five percent of complaints are routine. Dented packaging—annoying but not a safety issue. Usage questions—someone didn't read the manual. Requests for replacement—product worked fine, customer just wants a new one. Billing disputes—not even a product complaint. These complaints need handling, but they don't need urgency.

Five percent of complaints might indicate actual product issues. Device didn't perform as expected. Component failed during use. Patient experienced an adverse event. These need investigation.

And somewhere in that five percent, maybe one in a hundred total complaints, is something reportable. Death or serious injury. Malfunction that could cause death or serious injury if it recurred. These have regulatory deadlines measured in days, not weeks.

If your system processes complaints first-in-first-out, that one reportable complaint waits behind ninety-nine routine ones. By the time it reaches someone who recognizes its significance, the reporting window may already be closing.

Triage That Identifies Urgency

Seal triages at intake. Before a complaint enters the queue, structured questions classify its urgency. "Did this involve death or serious injury?" "Did the device malfunction during actual use?" "Was the device being used on a patient at the time?" The answers determine classification immediately.

If the answers indicate a potentially reportable event, the complaint doesn't enter the normal queue. It escalates immediately to personnel trained to assess reportability. The five-day clock is acknowledged from the moment of awareness. The countdown is visible on dashboards from day one.

If the answers indicate a routine complaint, it enters normal processing. Still tracked, still investigated appropriately, but not consuming the urgent attention that safety events require.

The triage isn't a guarantee of correct classification—initial information is often incomplete. But it catches the obvious signals immediately. The surgeon calling about a device failure during a procedure doesn't wait behind the customer complaining about packaging.

Investigation That Builds the Record

Once a complaint is triaged, investigation begins. What happened? What product? What lot? Who was affected? What were the circumstances?

The investigation needs the product when possible. Request returns, track shipments, document receipt. Physical examination often reveals information that narrative descriptions miss. Was there a manufacturing defect? Was it used correctly? Is there evidence of tampering or misuse?

When you can't get the product—it's still implanted, or the customer disposed of it, or they simply won't return it—document why and investigate with available information. Review manufacturing records for that lot. Check for similar complaints on the same product or lot. Examine whether your process could have produced this failure.

The investigation record builds automatically. Each data point links to the complaint. Photos attach to the physical examination. Manufacturing records link through lot numbers. Similar complaints surface through trending analysis. When the investigation concludes, the complete record is assembled—not in a separate report, but as the connected data that was captured as investigation proceeded.

The Pattern Nobody Saw

One battery complaint is an anomaly. Maybe a manufacturing defect, maybe customer misuse, probably not significant. Investigate, respond, close.

Three battery complaints in six weeks is a cluster. Coincidence? Different root causes? Starting to warrant attention.

Eight battery complaints across three lot numbers over three months is systemic. Something is wrong with the battery, the design, the manufacturing, or the supplier. This needs a CAPA, not just complaint closures.

The person handling complaint eight doesn't know about complaints one through seven in a traditional system. They're in different files, assigned to different investigators. Each investigator sees their complaint as an isolated event. Nobody sees the pattern.

Seal analyzes complaints across products, lots, symptoms, complaint codes, and time. When complaints cluster beyond statistical expectation, the system alerts quality leadership. The pattern becomes visible before it becomes a crisis. When you open complaint eight, you see that seven similar complaints have occurred recently. The systemic nature is obvious from the start.

Regulatory Reporting

When an event is reportable, the deadlines are fixed. MDR requires reporting within five calendar days for events involving death or serious injury, thirty days for malfunctions that could cause harm if they recurred. These aren't business days—weekends and holidays count.

When a complaint is classified as reportable, Seal calculates the deadline based on when you became aware. The countdown is visible on dashboards. As the deadline approaches, escalation intensifies. Three days remaining—notification to the supervisor. One day remaining—notification to quality leadership. Deadline day—red alert status.

The MDR form itself is prepopulated from complaint data. Device identification, event description, patient outcomes—information captured during intake and investigation flows to the report. You're not starting from scratch; you're reviewing and completing.

Submission tracking confirms the report reached FDA. Follow-up requirements are scheduled. If you submit a five-day report with incomplete information (because you often must), the system tracks the thirty-day follow-up deadline for additional information.

Global Vigilance

Complaint from Germany. Same day, another from Brazil. A week later, reports from Japan and Australia. The same failure mode appearing across multiple markets.

Four regulatory systems. Four different reporting requirements. Four different deadlines. Four different forms. EU Medical Device Vigilance isn't identical to FDA MDR isn't identical to Japan PMDA isn't identical to Australia TGA.

When a complaint is classified, Seal identifies which regulatory reports are required based on where the event occurred and where the product is marketed. The German complaint triggers EU vigilance requirements. The Brazil complaint triggers ANVISA requirements. Each jurisdiction's deadlines are calculated and tracked separately.

The investigation is one record. The regulatory reports are multiple, jurisdiction-specific outputs from that record. You investigate once; you report to each applicable authority based on their requirements.

From Complaint to Correction

Some complaints are isolated events—investigate, respond, close. Others indicate systemic issues requiring corrective action. The connection between complaints and CAPAs should be explicit, not assumed.

When investigation reveals a root cause affecting other products or lots, a CAPA initiates directly from the complaint. The complaint is the source event, providing context and evidence for the corrective action. When the CAPA completes, effectiveness verification can examine subsequent complaints—did the corrective action actually reduce the complaint rate?

Trending analysis identifies when complaints warrant CAPA even when individual investigations don't reveal obvious root causes. Eight complaints about the same issue, each investigated and closed individually, together indicate a systemic problem requiring systemic response. The system surfaces these patterns for quality leadership decisions.

AI that builds your complaint system

Setting up complaint handling traditionally means defining intake forms, triage rules, investigation templates, regulatory reporting workflows—weeks of configuration. AI compresses this.

Describe what you need: "We manufacture Class II medical devices sold in the US and EU. We need complaint intake with MDR/vigilance triage, investigation workflows, and trend analysis." AI generates the configuration—intake forms with appropriate fields, triage decision trees for reportability, investigation templates, regulatory report generation. You review and approve.

Triage rules build from regulatory requirements. AI understands what triggers MDR reporting, what triggers EU vigilance, what's a routine quality complaint. The decision trees it generates reflect current regulations—you verify they match your products.

Every AI proposal is transparent. Configuration changes go through your approval process. AI accelerates setup; your team controls the system.

And AI works within every complaint. At intake—AI analyzes the complaint text and flags potential reportable events immediately. "Device malfunction during surgical procedure" triggers escalation before the clock starts running unnoticed. During investigation—AI surfaces similar complaints across products and lots. "Eight complaints with similar failure mode across three lots." Pattern detection finds signals humans would miss until much later.

The Customer on the Other End

Complaints come from people. Patients who experienced problems. Healthcare providers who witnessed failures. Distributors who received damaged products. These people deserve responses.

Acknowledgment tracks when you confirmed receipt and set expectations for investigation. Updates track when you communicated status during investigation. Resolution tracks when you provided the final response—what you found, what you're doing about it, what the customer should do.

When the surgeon calls back six weeks later asking about their complaint, you don't search through files. Their history is immediate—complaint, investigation status, communications, resolution. You know what they reported, what you found, what you told them.

Response time SLAs ensure complaints don't languish. Acknowledgment within 24 hours. Investigation initiation within three days. Resolution within thirty days for routine complaints, expedited for safety issues. Metrics show whether you're meeting targets and where bottlenecks occur.

The goal isn't just regulatory compliance. It's maintaining trust with the customers and patients who depend on your products. Fast, thorough, transparent complaint handling demonstrates that you take quality seriously.