Decisions for regulated teams

Review every complaint, not a sample.

Plumb reads every complaint and call a regulated company receives. Each one gets a calibrated decision, the words that drove it, and a record an auditor can follow.

Send us 500 historical cases See how a decision is made

500 cases0 read

Read, reason recorded Flagged for a person

Two product lines

One engine, tuned per regulation.

Plumb for Device Complaints

An FDA reportability decision on every complaint, with the deadline attached.

2,888,003

device adverse event reports FDA received in 2025

Death, serious injury and malfunction scores
30-day and 5-day clocks shown from day 0
For quality and complaint-handling teams

Device complaints →

Plumb for Financial Compliance

Disputes, stop requests and risky statements flagged on every collection call.

322,041

debt collection complaints to the CFPB, Oct 2025 – Sep 2026

FDCPA, Reg F and TCPA questions on every call
Complaint triage inside the 15-day window
For collectors, debt buyers and lenders

Financial compliance →

Sources: openFDA device event API; CFPB Consumer Complaint Database.

How a decision is made

Text in. Scored questions. A route, with reasons.

Control

You decide where automation stops.

Every case gets a score. Below your line, it closes with the reason on file. Above it, a person reviews, riskiest first. Drag the line.

0.0 · not reportable1.0 · reportable

Threshold 0.20

70%

closed automatically, rationale recorded

30%

sent to a reviewer, highest scores first

Start conservative. Move the line only as calibration on your own cases earns it.

Illustrative distribution. Your real split comes from the backfill.

Audit trail

Every decision leaves a record an inspector can read.

Case	C-10492 · received 2026-09-14 09:12 · support call
Model	mdr-device-v1 · threshold 0.20
Scores	malfunction 0.86 · serious injury 0.41 · 5-day 0.04 · death 0.01
Evidence	"occlusion alarm" · "HIGH" · "reverted to manual dose injection"
Route	review · likely 30-day report · due 2026-10-14
Reviewer	confirmed · 2026-09-14 11:40
Outcome	report filed · decision and rationale kept in the event file

Illustrative record. Reviewer corrections are stored and used to retrain.

Why it holds up

Built for the person who has to defend the decision.

Every case

Score 100% of complaints and calls. People spend their time on the cases that need judgment.

Calibrated

A 0.94 means about 94 of 100 similar cases were positive, measured on held-out data from your own history.

Audit-ready

Each decision stores the model version, the score, the evidence text and who signed off.

The pilot

Prove it on your own history first.

Send

500 closed cases or calls, with the decisions your team made.

Score

We return every case scored in 48 hours, blind to your answers.

Compare

See where we agree, where we differ, and why, case by case.

Go live

A review queue, then an API. Corrections retrain the model.

AgreeBoth of us flagged it

AgreeNeither of us flagged it

Second lookPlumb flagged, your team closed

Our missYour team flagged, Plumb didn't. Shown openly.

Design partner program · 3 spots

Shape the model around your definitions.

A scored backfill of 500 of your past cases

A model tuned to your SOPs and policies

A direct line to the founders

Design partner pricing, locked

We ask for closed cases with your determinations, 30 minutes of feedback every two weeks, and a reference call if it works. Data terms are agreed before any file moves: see security and data handling.

Plumb for Device Complaints

Every complaint read. Every reportability call made.

Plumb gives each complaint a calibrated answer to the FDA's reporting questions, with the evidence and the deadline attached, so your team reviews the cases that need judgment.

Send us 500 closed complaints

The job

Every complaint is a reportability decision.

Device may have caused or contributed to a death or serious injury?

→Report in 30 days

Malfunction that would likely cause or contribute to one, if it recurred?

→Report in 30 days

Needs remedial action to prevent an unreasonable risk of substantial harm?

→Report in 5 work days

None of the above?

→Close. Record why.

21 CFR 803.50, 803.53, 803.18

The clock

It starts when any employee hears about it, not when QA opens the file.

Day 05 work days30 days A rep's email or a support call. Events needing remedial action. Deaths, serious injuries, reportable malfunctions.

21 CFR 803.3 ("become aware"), 803.50, 803.53

From FDA's record

What a wrong call looks like.

Warning letter · Dec 17, 2025

"Your firm has categorized complaints as feedback, resulting in the events not being documented and handled as complaints."

→FEEDBACK

Abdominal swelling in 8 of 10 patients, closed without investigation. Two more injuries judged not reportable; FDA disagreed.

Mast Biosurgery USA, letter 720661

Warning letter · Sep 23, 2025

"The fact that the malfunction occurred once leads to the presumption that the malfunction will recur."

May 9, 2022 awareSep 2025: no report

An airway tube cuff failed a pre-use check. 30 days allowed; 1,233 days later FDA still had no report.

Insung Medical, letter 712545

Form 483 · Nov 2021

222,000+

complaints since 2008 matching FDA's keyword search, e.g. "foam," "debris"

$1.7B+

settled: $1.1B personal injury, $613M+ economic loss. About 15M devices recalled.

FDA found "no documented investigation." No team reads 222,000 complaints. Software can.

Philips Respironics; RAPS, NBC, NPR

Three complaints

One sentence each. Three different calls.

Dental implant

"The implant at tooth site #11 was removed due to bone loss."

Serious injury0.79

Review: surgery to remove device

Neurovascular catheter

"Unable to deliver coils through the micro catheter... the second case today in which this occurred."

Harm if it recurs0.83

Review: repeat malfunction

Surgical stapler · illustrative

"Outer carton arrived crushed. Sterile pouch intact, device not used."

Reportable0.03

Auto-closed, reason recorded

Quotes 1–2 from public FDA MAUDE reports (Sep 2025), manufacturer names removed. All scores illustrative.

Send us 500 closed complaints.

We'll score them in 48 hours and show you every place we disagree.

Apply for a design partner spot

Plumb for Financial Compliance

Every collection call read, not one in a hundred.

Plumb flags disputes, stop requests and risky statements on every call and complaint, with the exact words, so QA reviews the calls that matter instead of a random sample.

Send us 500 calls

The job

Every call is a string of compliance decisions.

Before the dial

More than 7 calls in 7 days?

Outside 8am–9pm local time?

Consent to call this cell?

Opening

Right person confirmed before the debt comes up?

Said this is an attempt to collect a debt?

Conversation

Consumer disputed the debt?

Asked us to stop contacting them?

Agent threatened, misstated or pressured?

After

Dispute logged and collection paused until verified?

Account notes match what was said?

The dialer can enforce these.

Only reading the call catches these. Today that's a QA sample.

FDCPA §§ 805, 807, 809; Reg F 12 CFR 1006.14; TCPA 47 U.S.C. 227

The volume

322,041 debt collection complaints to the CFPB in 12 months.

CFPB Consumer Complaint Database, debt collection, received Oct 1, 2025 – Sep 30, 2026. 11,176 got a late company response.

The cost

Damages are counted per call.

bad dialer setting

10,000

calls before anyone notices

$500

TCPA minimum per call

$5,000,000

$15M if willful

400+ / mo

FDCPA lawsuits filed (458 in Dec 2025, 396 in Jan 2026). Up 7.8% in 2025.

~220 / mo

TCPA lawsuits filed over the same months.

$500K or 1%

FDCPA class damages cap, whichever is less, of net worth, plus the plaintiffs' legal fees.

Arithmetic example, not a case. 47 U.S.C. 227(b)(3); 15 U.S.C. 1692k; WebRecon filing data.

2025–2026

Federal enforcement pulled back. The exposure moved.

Pulled back

Debt collection enforcement actions: 9 in 2025, down from 16 in 2024, 6 of them by the FTC. The CFPB proposed raising the bar for federal supervision and stopped publishing complaint narratives on Aug 14, 2026.

Still there, or growing

Consumers still file with the CFPB and you still respond. Private FDCPA suits rose 7.8% in 2025. States are adding rules and investigators. Old consent orders still bind: in 2023 Portfolio Recovery Associates agreed to pay over $24M for breaking a 2015 order, including promising documents it never sent.

Goodwin, Debt Collection Year in Review (Mar 2026); CFPB v. Portfolio Recovery Associates (Mar 2023); WebRecon.

Three moments

The calls behind the top complaints.

Consumer

"That's not my debt. I've never had an account with them."

Debt disputed0.95

Flag: dispute

CFPB "debt is not yours": 89,058

Consumer

"I'm asking you to stop calling me. Put it in a letter."

Asked to stop contact0.92

Flag: stop calls, mail only

CFPB "told them to stop, they kept trying": 4,505

Agent

"If this isn't paid by Friday it goes on your credit and we take next steps."

Possible false threat0.71

Review: is it true?

CFPB "threatened credit damage": 73,781

Quotes and scores illustrative. Complaint counts from the CFPB database, Oct 2025 – Sep 2026.

Send us 500 calls.

We'll score every one in 48 hours and show you what your sample didn't hear.

Apply for a design partner spot

Security and data handling

Your data stays in our account, scores only your cases, and is deleted on request.

The answers quality and compliance teams ask for first. Questions or a security review: security@plumblabs.ai.

What data do you need?: For a pilot, 500 closed cases: the complaint or call text, its date, and the decision your team made. We don't need patient or consumer names, account numbers or contact details. Remove them before export where you can.
How do we send it?: Through an encrypted upload link we issue per customer. Never by email attachment.
Where is it processed?: In our own Cloudflare account. Files are stored in U.S. data centers, and the models run on Cloudflare Workers AI under our account, not through an outside AI company's API. Cloudflare does not use customer content to train its models.
Who can see it?: Only Plumb staff working on your account, named on request. Access requires multi-factor authentication and is logged.
How is it protected?: Encrypted in transit (TLS 1.2 or higher) and at rest (AES-256). Each customer's data sits in its own storage, separate from other customers'.
Do you train on our data?: Only to tune the model that serves you. Your cases and corrections never train another customer's model, and we don't pool data across customers without your written consent.
How long do you keep it?: Pilot data is deleted within 30 days after the pilot ends, unless you become a customer. Backups expire within 35 days. We confirm deletion in writing on request, and you can ask us to delete everything at any time.
What about health data?: Device complaints can include health information. Device makers are usually not HIPAA covered entities, but we sign a business associate agreement on request and treat all complaint text as sensitive either way.
What about consumer financial data?: Collection calls and complaints include consumer financial information. We act as your service provider, use it only to deliver the service, and contract to the safeguards the Gramm-Leach-Bliley Act and the FTC Safeguards Rule expect of service providers.
Call recordings?: We prefer transcripts. If you send audio, we transcribe it with an open-source speech-to-text model running on Workers AI under our account.
What if something goes wrong?: We notify you within 72 hours of confirming an incident that affects your data, with what happened, what data was involved and what we're doing about it.
Who else touches the data?: Customer data: only Cloudflare, our infrastructure provider. We list every subprocessor and give 30 days' notice before adding one.
Certifications?: We don't hold SOC 2 or ISO 27001 yet. We'll complete your security questionnaire and walk your security team through this setup.
What does Plumb decide?: Nothing on its own. Plumb scores cases and routes them by thresholds you set. Your team makes and owns every regulatory determination and filing.

We collect little, use it only to run Plumb, and never sell it.

Who we are

Plumb Labs, LLC ("Plumb", "we") runs this website and the Plumb service. Contact: privacy@plumblabs.ai, [street address].

What this policy covers

People who visit our website, contact us, or receive email from us. It does not cover the complaint, call and case data customers send us to score. We process that data only on our customers' instructions, under our agreement with them and our security and data handling commitments. If your information appears in a customer's data, contact that customer.

What we collect and why

Where it comes from	What we collect	What we use it for
The design partner form, or an email you send us	Name, work email, company, product line, your message	Replying, evaluating fit, and running a pilot if you join
Public and commercial business sources	Name, job title, company, work email	Contacting people at companies Plumb may help
Our website servers	IP address, browser type, pages requested, time	Security and fixing errors. Kept 30 days

We don't use analytics, advertising or tracking cookies.

What we don't do

We don't sell personal information, share it for cross-context behavioral advertising, or use it to train models.

Who we share it with

Service providers that help us operate, under contract: our email host (Google Workspace) and our infrastructure provider (Cloudflare), which also runs this website and its contact form.
Authorities, when the law requires it.
A buyer or successor, if Plumb is sold or merged, under the same commitments.

Emails from us

Every email we send says who we are and how to stop hearing from us. Reply "unsubscribe" or use the link, and we stop within 10 business days. We keep your address on a do-not-contact list so it stays that way.

How long we keep it

Inquiry and contact records: 24 months after our last exchange, then deleted. Do-not-contact list: as long as needed to honor it.

Your choices

You can ask what we hold about you, and ask us to correct or delete it, at privacy@plumblabs.ai. We answer within 45 days, whether or not a state privacy law requires it.

Security

We protect personal information with encryption, access limited to staff who need it, and multi-factor authentication.

Children

Plumb is a business service. We don't knowingly collect information from anyone under 18.

Where data is stored

In the United States.

Changes

We post changes here with a new effective date, and email customers about material changes before they take effect.

You own your data. Your team owns every decision.

These terms govern business use of Plumb, including pilots. Either side can end a pilot on 30 days' notice.

Agreement. These terms, plus any order form or pilot form we both sign, are the agreement between Plumb Labs, LLC ("Plumb") and the company using the service ("Customer"). If an order form conflicts with these terms, the order form controls.
The service. Plumb scores complaint, call and case text against questions agreed with Customer, records the evidence behind each score, and routes cases by thresholds Customer sets. A pilot is a limited trial, normally a backfill of up to 500 historical cases, as described in the pilot form.
Decision support only. Scores are probabilities and can be wrong. Plumb does not file reports, make regulatory determinations or give legal advice. Customer remains responsible for every determination, filing and response, including those under 21 CFR Part 803, the FDCPA, Regulation F and the TCPA, and for the thresholds it sets.
Customer data. Customer owns all data it sends ("Customer Data") and all outputs about it. Customer gives Plumb a limited right to use Customer Data only to provide the service to Customer and to tune Customer's own model. Plumb will not use Customer Data to train models for anyone else, sell it, or disclose it except as these terms allow. Plumb may use counts and performance measurements that contain no Customer Data content to run and improve the service.
Customer responsibilities. Customer will send only data it has the right to share for this purpose, remove personal identifiers that scoring doesn't need where practical, and keep its account credentials secure. Customer will not reverse engineer the service, use it to break the law, or send data it obtained unlawfully.
Security and confidentiality. Plumb protects Customer Data as described on the security and data handling page and notifies Customer within 72 hours of confirming an incident affecting it. Each party keeps the other's confidential information confidential and uses it only for this agreement. On request, or within 30 days after the agreement ends, Plumb deletes Customer Data and confirms in writing.
Plumb's property. Plumb owns the service, its software and its general models, excluding Customer Data. If Customer offers suggestions, Plumb may use them without obligation.
Fees. Fees are set in the order form. Pilots are free unless the pilot form says otherwise. Invoices are due within 30 days and exclude taxes.
Term and ending. A pilot runs for the period in the pilot form, 60 days if none is stated. Either party may end a pilot for any reason on 30 days' written notice, or end any order for a material breach the other party leaves uncured for 30 days after notice.
Warranties. Plumb will provide the service with reasonable skill and care. Otherwise the service is provided as is: Plumb does not promise that scores will be accurate or that using Plumb will make Customer compliant with any law.
Limits of liability. Neither party is liable for indirect, consequential or punitive damages or lost profits. Each party's total liability is limited to the fees Customer paid in the 12 months before the claim, or $10,000 for a free pilot. These limits don't apply to breach of confidentiality, the indemnities below, or a party's gross negligence or willful misconduct.
Indemnities. Plumb defends Customer against third-party claims that the service infringes their intellectual property. Customer defends Plumb against third-party claims arising from Customer Data that Customer had no right to share.
Law and venue. New York law governs. Disputes go to the state or federal courts in New York County, New York.
General. Neither party may assign this agreement without consent, except to a successor of its business. Notices go to the addresses in the order form. Plumb may update these terms with 30 days' notice, and changes don't apply to a signed order until it renews. This is the entire agreement on its subject.

Questions: legal@plumblabs.ai.