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Device Quote Review Kit

Ten checks to run before a capital-equipment agreement moves from sales conversation to signed contract.

This checklist is an editorial research aid, not medical, legal, tax, clinical, or financial advice. Verify primary records and use qualified advisers for your decision.

Last updated: 2026-08-25

Use one copy for each quote

Complete the fields from primary records and the written agreement. Label company statements as company-reported. Keep market observations dated and scoped. Leave a box open when the evidence is missing.

Device / model:Vendor:Quote date:Decision owner:

Gather these records before you start

Use the current written quote, product labeling, FDA decision record, recall search, service schedule, warranty, software terms, training scope, consumable schedule, financing agreement, and any study the vendor uses to support a material claim. Save the publication or decision date with every source. A screenshot or sales slide can help locate a claim, but it should not replace the underlying record.

Run one worksheet for each competing configuration. Use the same collection, treatment-volume, staffing, downtime, financing, and resale assumptions across options. If a field cannot be verified, label it unknown. That keeps a company statement, a market observation, and your own forecast from being treated as the same kind of evidence.

Bring the completed worksheet to the vendor review and assign each open question to a named person. For any answer that changes price, support, permitted use, or exit cost, ask where that term appears in the final agreement. Recheck the configuration and attachments before signature because a revised quote can change the equipment bundle, warranty dates, software term, or financing schedule without changing the sales summary.

Keep the completed record with the signed contract for later reference.

1. Identify the exact system

Record the legal manufacturer, marketed name, model number, configuration, serial number, manufacturing year, and software version.
List every handpiece, applicator, accessory, cart, license, and starter consumable included in the written quote.
For used equipment, confirm title, ownership history, hours or pulse count, and whether any lien remains.

2. Match the regulatory record

Open the primary FDA record for the exact model and save the decision number, date, product code, and stated indication.
Check current recall records by model and, when possible, serial number or software version.
Do not treat clearance as proof of superiority, reimbursement, or performance outside the stated scope.

3. Test the clinical evidence

Separate peer-reviewed studies from company materials, conference abstracts, case series, and testimonials.
Record sample size, comparator, follow-up period, patient population, endpoints, funding, and important exclusions.
Write down what the evidence does not establish for your patients, operators, setting, and protocol.

4. Reconcile every dollar

Separate equipment price from tax, freight, installation, training, software, handpieces, consumables, and required facility work.
Ask which prices are fixed, which can change, and how long the quote remains valid.
Model a conservative case using your own volume, collection, utilization, staffing, financing, and downtime assumptions.

5. Put service terms in writing

Record warranty start date, duration, exclusions, travel charges, parts coverage, labor coverage, and preventive maintenance requirements.
Name the service provider, escalation path, response target, loaner policy, and remedy if the device remains unavailable.
Verify parts and service availability in your region instead of relying on a verbal assurance.

6. Verify software and data terms

List required licenses, subscriptions, connectivity, updates, cybersecurity obligations, and fees after the first year.
Confirm whether the system can be operated, serviced, transferred, and updated after a resale or practice ownership change.
Document what data leaves the device, who controls it, and what happens when a subscription ends.

7. Define training and workflow

Name every operator who will be trained and whether training is onsite, remote, initial, recurring, or certification-based.
Estimate room, setup, turnover, cleaning, documentation, staffing, and patient-selection time in addition to treatment time.
Confirm who handles protocol questions and adverse-event escalation after launch.

8. Price the consumable path

List required single-use items, minimum orders, expiration periods, shipping, storage, and expected waste.
Ask whether consumable pricing can change and whether the system requires proprietary supplies to remain functional or supported.
Run the downside case with lower utilization and higher consumable cost than the sales projection.

9. Check transfer and exit terms

Record cancellation, return, early payoff, personal guarantee, insurance, relocation, assignment, and ownership-transfer terms.
Ask about de-installation, shipping, re-installation, inspection, recertification, and software transfer fees.
Get the trade-in formula and any repurchase promise in the signed agreement, not in a sales email.

10. Create the decision record

List the competing systems and use the same evidence and cost fields for each.
Write the three assumptions most likely to make the purchase fail and the evidence that would change your decision.
Record unresolved questions, owner, source, and due date before signing.

Before you sign

Attach the source record, final quote, service schedule, training scope, consumable schedule, and your downside model. A blank field is a question to resolve, not a reason to guess.

Frequently Asked Questions

Is the Device Quote Review Kit specific to new equipment?

No. Use it for new, used, refurbished, financed, or leased equipment. A used-device review needs extra attention to title, serial-number history, hours or pulse count, software transfer, service eligibility, applicator condition, recertification, and return terms. The checklist identifies those fields without assuming that a lower purchase price produces a better or safer decision.

Does an FDA clearance answer whether I should buy a device?

No. A clearance record helps identify the device, product code, decision date, and stated regulatory scope. It does not by itself establish clinical superiority, financial return, reimbursement, operator fit, or performance outside the cleared scope. Pair the record with applicable evidence, the written quote, service terms, and your own operating assumptions.

What should I do when a vendor will not answer a checklist item?

Leave the item open, record the request and response, and decide whether the missing term changes your willingness to proceed. Ask for material commercial promises in the signed agreement. For regulatory and evidence questions, open the primary record yourself. Device Pulse does not interpret a missing response as proof of a safety, performance, or financial problem.