★ Brief · quote comparison · landed cost · deposit · importer of record

For the person who has to put a number in a spreadsheet

From brief to a number you can defend.

Fourteen of the questions buyers send us are about their own desk: what to put in the brief, how to read the quote that comes back, what the order costs once it lands, and what a deposit is supposed to look like. None of it is about the product, and all of it is where a first order is won or lost.

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The buyer's desk is the part of sourcing nobody photographs. It is six documents and one spreadsheet, and it is the only place where two suppliers quoting the same unit price produce different margins. This page is ordered the way the work happens — brief out, quotes in, landed cost calculated, deposit sent, entry filed — because each step constrains the one after it.

What has to be in a sourcing brief for it to come back comparable?

Six lines, and the point of the brief is not politeness — it is that two suppliers answering the same six lines produce two quotes you can put in the same column. The product type or model, three quantity tiers with a unit price at each, whether you want a public or private tool and who owns it, the material grade you will accept, the certificate pack your market requires, and your sampling and lead-time expectations. Which lines come back blank tells you more than the ones that get answered.

  • Product type or reference model — not a mood board
  • Three quantity tiers, unit price at each
  • Tool: public or private, and ownership after payment
  • Material grade you will accept, stated as a standard
  • Certificate pack required by the destination market
  • Sampling and lead-time expectations, in weeks

The brief is the only document that costs nothing and saves the most

A brief sent as a chat message gets answered as a chat message: a price, a MOQ, an "ok friend". The same factory, asked the same question in six numbered lines, answers in six numbered lines — because a structured question is visibly a buyer who will compare the answers, and comparing answers is the only leverage a first-time buyer has.

The line that matters most is the one most often left out: who owns the tool after it is paid for. A mould paid for in full and still owned by the factory is a mould you cannot move, and the invoice will not say so. It belongs in the brief, in the purchase order, and in the contract, in that order, because each one is harder to change than the last. Our manufacturing page sets out the three tooling positions a quote can take.

The four numbers hiding inside one "low MOQ" quote

A quote that leads with a low minimum is not lying; it is quoting a different product from the one you asked about. Four numbers move when the minimum drops, and a quote that shows only the first is a quote you cannot compare.

The four numbers inside one "low MOQ" quote
What movesWhat to askWhy it decides the comparison
Unit price at that quantityThe price at each of your three tiersA 50-unit price and a 500-unit price are different products at the same name.
Setup and toolingItemised, separately from the productSetup is fixed. Spread over 50 units it dominates the unit cost and disappears at 1,000.
Packaging minimumThe minimum on the box, not on the devicePrint runs have their own minimum, and it is frequently higher than the product's.
Payment termsDeposit percentage, balance trigger, currencyTerms are a financing cost. 100% upfront on a first order is a price increase with no number on it.

Reading quotes is therefore an exercise in normalising, not in choosing. Put the four lines side by side, convert every currency to one, and add the setup amortised over the quantity you actually intend to buy in year one rather than over the first shipment. The supplier who looks cheapest at the top of the page is regularly the most expensive at the bottom of the sheet.

Landed cost replaces unit price

Unit price is a factory number. Landed cost is the number your business actually pays, and the difference between them is freight, duty, brokerage, the destination charges nobody quotes, and the cost of the money tied up while the container is in transit. A first order priced on unit price alone is a margin calculated on about two thirds of the invoice.

The arithmetic is not difficult, which is why the omission is surprising. Product cost plus packaging plus tooling amortisation, plus freight to the destination port, plus duty at the classification rate, plus brokerage and destination handling, plus inland delivery, plus the financing cost of the deposit for the days it is outstanding. Every line is knowable before the order is placed. The classification is the one line that is genuinely your responsibility rather than the supplier's, and it is worth a broker's fee to get it right once rather than to discover it at the border.

The deposit: what is normal, and the one detail that loses it

The working norm for a first order in this category is a deposit and a balance rather than payment in full — commonly 30% to start and 70% against documents or against a passed inspection. 100% upfront from a supplier you have not bought from before is not a discount opportunity; it is the entire risk of the transaction moved onto you before a single unit exists.

The detail that loses deposits is not the percentage. It is the name on the receiving account. A deposit paid to an account whose beneficiary differs from the contracting legal entity is a payment to a different company, and recovering it means proving a relationship between two entities that the paperwork was careful not to state. Confirm the beneficiary in writing, on the contract, before the first transfer — and treat a late change of bank details as the fraud pattern it usually is, whatever the explanation.

Importer of record, EORI, and who is liable under DDP

The importer of record is the party legally responsible for the entry — for the declared value, the classification and the duty. It is not automatically the factory, and it is not automatically your forwarder, and the assumption that it is either is how a brand discovers a liability it did not know it had. Whoever is named on the entry is the party a customs authority will pursue, and that liability survives an Incoterm that says someone else pays — see the Wikipedia entry on Incoterms for why "pays" and "is liable" are two different questions.

Under DDP the seller pays duty, which is convenient and which quietly makes the seller the importer in most practical arrangements. If the entry is then wrong — a classification that understates duty, a value that omits a component — the correction lands on the party named on the entry, and a brand that assumed DDP meant "not my problem" finds out at the audit. An EORI number is required for anyone acting as importer into the EU or the UK; if you do not have one and never intended to be the importer, that is the moment to confirm the structure rather than after the container has arrived.

The calendar decides the quantity before the quantity does

The last line of the desk is scheduling, and it runs backwards. A shelf date is fixed by a retailer; the delivery date is that minus the receiving window; the ship date is that minus the freight leg; the production start is that minus the production run; the sample approval is that minus the sampling leg; and the brief is that minus the two days it takes to scope. Working backwards is what tells you whether you have time for a colour development or whether you are buying from stock, and those are different products at different prices.

The recurring failure is not a late factory. It is a brief sent in the week the calendar had already closed, which converts a planned private-label order into an air-freighted stock order at three times the landed cost. The production calendar, including the Chinese New Year shutdown that moves every date in the first quarter, is on the MOQ and pricing guide.

Lead time is not one number, it is five legs — and the two longest are the two no supplier ever quotes in the same sentence.

Where the ninety days actually go

Brief to a written scope 2 days
Sample made and delivered 5 days
Bulk production 30 days
Sea freight, port to port 32 days
Marketplace or 3PL check-in 7 days

Highest in this set: Sea freight, port to port at 32 days.

Where the ninety days actually go. The five legs of a first private-label order, each at the midpoint of the range published for this category: a written scope in about two days, a sample from a stock platform in about five, bulk production at 25–35 days, sea freight at 25–38 days door to door, and about a week for a marketplace or a 3PL to check the delivery in. They sum to roughly eleven weeks, which is why the page says two to three months rather than six weeks. No leg here was measured on our own shipments: the midpoints are arithmetic on published ranges, and a colour development or a new mould adds a sixth leg on top rather than compressing any of these five.

The document chain: what each piece of paper is for

A quotation is an offer, not a record of the deal. What travels into production is a short chain of papers with different jobs: the proforma invoice states quantity, price and payment terms before money moves; the purchase order is the buyer's formal instruction to build; the commercial invoice is the document a customs authority assesses duty against; and the packing list says how many cartons, what net and gross weight and which marks are on the pallet. Treating the last two as clerical copies of the first two is how a first shipment gets held: the proforma invoice and the commercial invoice routinely carry different numbers, and the entry is filed against the latter.

The specification behind them is a bill of materials, and the version that actually governs a build is the approved component list: a twenty-part device looks identical after one cell or one connector changes, while the test report on file no longer describes what was made. One-off development work is quoted as non-recurring engineering and is not tooling, and the longest single item on the schedule is usually a long-lead component with a minimum of its own at a sub-supplier. When a setup fee appears, ask which of the two the factory is pricing, because only one of them can be moved to a second factory.

Verification is a document too, not a promise in a chat thread. A during production inspection catches drift at 20–30% of the run; a final random inspection samples the finished lot against an agreed acceptance level; and the reference both are measured against is the signed sample with its Delta E tolerance written down rather than remembered. A sample credit that refunds the sampling fee against the first bulk order belongs in the proforma invoice in writing, next to the price breaks at each quantity tier and the reorder minimum that will govern the second order. Six of these papers cost nothing to write before the deposit and are expensive to reconstruct afterwards.

The rest of the desk

The six pages below are one workflow cut into six answers. This page is one stage of it; the other five are linked here because the stage after yours is where most first orders go wrong.

The overview — what we do, what can be bought, and what cannot — stays on the brands, retailers and distributors page.

What this page rests on

Every figure on this page is a published range for this category, stated as a range, or arithmetic on assumptions printed next to it. Where a rule is named — the EU General Product Safety Regulation, the packaging regulation, GS1 prefix licensing, AQL sampling under ISO 2859-1 — the rule is the source, and a reader can open it. No number here was measured on our own bench: the bench data belongs to the reviews, and this page says so rather than borrowing their authority.

Sources cited

  1. Incoterms — the International Chamber of Commerce rules that separate who pays from who is liable: Incoterms.
  2. Letter of credit — the instrument behind a balance-against-documents term.
6lines that make two quotes comparable
30/70deposit and balance, the working norm
7lines in a landed cost that unit price omits
0suppliers we would pay in full before a unit exists

Questions about the brief, the quote and the deposit

The buyer-desk questions from the old /for-brands/ page, unchanged: brief content, quote comparison, landed cost, deposit norms, payment detail, importer of record and EORI.

Can I start with one SKU or do I need a range?

Start with one. The founders who lose money in this category are the ones who order six SKUs before they know which one their audience wants, then pay to store the other five. Add the second SKU when the first has consistent sell-through and repeat customers, and let the colour, size or accessory your customers ask for tell you what it should be.

What should a sourcing brief contain?

Six things, and the brief is better than a first email because it forces the answers to come back in comparable form: the product type or model, three quantity tiers with a unit price at each, whether you want a public or private tool and who owns it, the material grade you will accept, the certificate pack your market requires, and your sampling and lead-time expectations. Which lines come back blank tells you more than the ones they answer.

Do you arrange freight, customs and duties?

We can route you and tell you what the paperwork requires, but the classification is yours to confirm. Most silicone devices enter the US under HTS 3926.90.9990, while a device whose primary character is the motor may fall under Chapter 85 — and the code drives the duty rate, so confirm it with a licensed customs broker rather than a supplier's forwarder. Anything with a lithium cell needs UN38.3 to fly.

What is the realistic timeline from brief to first shipment?

Sampling is the leg that moves: three to five working days from a stock platform, longer if a colour or a mould is being developed. Bulk production then typically runs 25 to 35 days after sample approval, and freight is on top of that. The honest planning number for a first private-label order is two to three months from brief to delivery, and the delays almost always happen in the leg founders assumed would be quick.

When should I place my holiday order for an adult wellness brand?

By late August if you want stock for the December peak. Google Trends shows the category peaking in December with secondary peaks in April and July, and Black Friday–Cyber Monday is the sharpest single week. The replenishment cycle is long: 25–35 days of production, 25–38 days of sea freight and about a week of marketplace check-in — two to three months end to end. Set a reorder trigger at 6–8 weeks of remaining stock and add two weeks of safety stock. An October order is a salvage operation, not a plan. Also plan around Chinese New Year, which stops the factory for weeks. Our MOQ pricing guide covers the cost side of that cycle.

What is total landed cost, and why does it replace unit price in 2026?

Landed cost is what a unit actually costs by the time it is sellable: unit price plus freight, insurance, duty, customs fees, local delivery, and the cost of inspection, defects and rework. It replaced unit price as the number procurement teams manage because tariff rates can move in weeks while a purchase price locked in months earlier cannot. Two suppliers quoting the same unit price can differ substantially at the border — one packs efficiently onto a fast routing, the other adds dimensional weight and a higher duty classification. Ask every supplier to quote on the same Incoterm so you are comparing like with like, and treat the cheapest quote as a hypothesis rather than a result.

How much of a deposit is normal, and how much is a warning?

For a first order with a supplier you have not verified, 30% is the conventional ceiling and 20% is commonly negotiated; a deposit is normal and is not itself a signal. What is a signal is a large deposit demanded by a weakly verified supplier — practitioners repeatedly describe 50% to 70% upfront followed by slower replies once production starts. That pattern is not proof of bad faith, but it raises the verification burden, because once the deposit is wired the buyer has very little room to react. Verify before the deposit rather than after it, and use staged milestones: a deposit, then the balance against inspection or shipping documents.

What is the single payment detail that catches most lost deposits?

A bank account held in a different name from the company you are buying from. That mismatch is behind a large share of lost-deposit accounts and it is free to check: request the business licence, confirm the legal entity matches the bank beneficiary, and stop if it does not. Related flags are pressure to move the conversation off-platform, refusal to use any escrow or trade-assurance mechanism, urgency framed as a price that expires today, and a registered address that maps to an office rather than a plant.

What does a realistic first-order quantity look like if the calendar is tight?

It depends on whether the calendar leaves room for one production run or two. If there is room for two, the first order can sit at the factory's entry minimum and the second can be placed against real sell-through — which is usually cheaper in total cash even at a worse unit price, because the second spend is on inventory already proved to sell. If there is only room for one run, the first order has to cover the whole season, and that is the moment buyers accept a quantity they cannot afford. Work back from the shelf date first and let that arithmetic set the quantity, not the other way round.

Should a first order go by air or by sea?

Sea, unless a genuine deadline says otherwise — ocean freight is dramatically cheaper per unit, and defaulting to air because a booking was late is one of the most expensive habits a brand can have. Air is the right call only for high-margin goods or a real window such as a peak-season restock where a stockout costs more than the freight. The better fix is calendar discipline: book ocean space before production ends rather than paying for speed after it slips, and treat freight as the line most often missing from a first quote.

Who is the importer of record on my shipment — me or the factory?

The importer of record is whoever is named on the customs entry, and it is the factory only if the factory holds a legal entity in the destination country. That party owes the duty, has to be able to produce the entry, and is the one a regulator contacts when a consignment is stopped. A supplier who quotes DDP without an entity where you are importing is usually having a broker enter the goods under someone else's name. Read that name off the paperwork before the first container ships, because it is the name any penalty is addressed to.

Do I need an EORI number, and when does it apply?

If you are the importer or the declarant into the EU or the UK, yes: an EORI is the identifier every customs declaration is filed under, and a consignment cannot be cleared in your name without one. It is issued to a business established in that customs territory, it is free of charge, and it is a different number from your VAT registration. Ask the supplier for theirs when they claim DDP — a duty-paid quote from a seller with no EORI in your market means the entry is being made for you, not by them.

Under DDP, who pays the duty — and who is still liable if the entry is wrong?

DDP allocates the cost to the seller: they deliver cleared for import with duty and import VAT paid. It does not move the customs debt on its own. If the entry is lodged in your name, the authority can pursue you for an underpayment even though your invoice said duty-paid, and you then recover from the seller separately. So the three things to write into the contract are who files, whose name sits on the entry, and what happens if the classification is revised after the goods have landed.

Is a proforma invoice the same as a commercial invoice?

No. A proforma invoice is a seller offer issued before payment, listing the proposed goods, quantity, price and terms. A commercial invoice is issued against the actual shipment and is what a customs authority uses to assess duty. They can carry different totals legitimately; a supplier who sends only one document for both jobs usually means the entry will be filed on numbers nobody has checked.

What should a purchase order repeat from the sourcing brief?

At minimum the reference model, the exact quantity tier, the unit price at that tier, the material grade, the certificate pack, the packaging specification and the tooling-ownership clause. A purchase order that only says a quantity and a price silently drops everything the brief was written to fix, and the contract is then the first place those terms reappear — too late to change cheaply.

What does a packing list show that an invoice does not?

Physical structure: carton and pallet counts, units per carton, net and gross weight, dimensions and shipping marks. A forwarder and a customs officer use it to reconcile the cargo with the entry. An invoice answers what was sold and for how much; a shipment can be perfectly invoiced and still be held because the carton count on the pallet does not match the list.

Why does a bill of materials need an approved component list?

Because a bill of materials describes what a device is built from, while an approved component list says which specific parts and which named alternatives are permitted. Without the second document a factory can substitute a cell, a connector or a resin that looks identical and keep the same BOM description, while the test report on file no longer covers the product that ships.

Is non-recurring engineering just another name for tooling?

No. Tooling buys a physical object — a mould, a jig, a printing plate — whose ownership and storage can be negotiated. Non-recurring engineering pays for one-time development work such as programming, firmware setup or a test fixture design, and there may be nothing to take to a second factory. Ask for the two as separate lines; a single blended setup fee hides what you would own.

What is a long-lead component and who owns the delay?

It is the one part whose supplier minimum or production queue sets the whole schedule — often a specific cell, motor or custom-coloured resin. The assembly run can be short and still wait six weeks for that part. Whoever accepted the delivery date without asking which component has the longest clock owns the delay, so ask for the longest lead time as its own line in the quote.

When should a during production inspection be booked?

Against a percentage of completion, not a date on a calendar — commonly 20 to 30 percent of the run. Booking it by date means the inspector can arrive before the line has settled or after the whole lot is finished, and neither visit catches drift while it can still be corrected. Put the trigger, the sampling level and who pays for a re-inspection into the purchase order.

What does a final random inspection prove, and what does it not?

It samples a finished lot against an agreed acceptance level and says whether that lot may ship. It does not prove that every unit is good, that the components match the approved list, or that the next lot will be the same. For those you need the component-level records and the signed reference sample; a passed inspection is a release decision, not a quality certificate.

Where should a sample credit and price breaks be written?

In the proforma invoice, as separate lines, before any deposit is sent. A sample credit promised in a chat message is unenforceable once the bulk invoice is raised, and price breaks quoted only for the first tier give no way to price the second order. Write the credit, each tier and the validity date into the same document the finance team will approve.

Is the reorder minimum the same number as the first MOQ?

Rarely. The first minimum is set by tooling, setup and custom packaging; a reorder on an existing tool can be smaller, or larger if the factory books a full production slot. Ask for both numbers in the brief. A buyer who budgets the second order at the first order minimum either overstocks or discovers the factory will not run the quantity they planned.

What does Delta E tolerance mean on a signed sample?

It is the measured colour difference a production lot is allowed to show against the approved sample. Writing a number turns a colour argument into a checkable test; without it, two people can look at the same box under different light and both be sincere. Agree the light source and the number together, and reference both in the purchase order.

Which documents should exist before a first deposit is wired?

Six: a signed reference sample with its tolerance, a written specification with an approved component list, a proforma invoice with payment terms and sample credit, a purchase order repeating the brief, an agreed inspection trigger, and a confirmed bank beneficiary matching the contracting entity. None costs anything to produce; all six are expensive to reconstruct after money has moved.

What is the difference between a pre-production sample and a production sample?

A pre-production sample is built to your written brief before the run starts, so it proves the specification was understood. A production sample is pulled from the actual run, so it proves what is in the cartons. Approving the first and shipping against the second are two different decisions; a stock sample proves neither.

Why should a sample sign-off name the packaging as well as the device?

Because the box is part of the specification. A sign-off that approves only the device leaves artwork version, insert card, barcode, retail-box fit and finish free to change later. Record the version, the stated exceptions and the date in one approval file, so a later revision cannot be mistaken for the approved one.

Can one approved sample prove batch consistency?

No. A single unit shows what a factory can make on a day when someone was paying attention; it says nothing about unit one thousand. Batch consistency needs a sampling plan, an agreed acceptance level and a dated inspection report. Ask for the protocol, not for a second identical sample.

What should an artwork proof fix before printing starts?

Spelling, the exact logo version, the colour reference, imprint size and placement, and the product colour underneath it. A proof is a contract for what will be printed, not a preview to browse on a phone. For a custom colour ask for a physical swatch as well, because a screen proof hides colour drift.

Who defines critical, major and minor defects before an inspection?

The buyer does, in writing, with the factory agreeing before production. Without that list two inspectors grade the same carton differently and a failed report becomes an argument about adjectives. Put the definitions, the sampling level and who pays for a re-inspection into the purchase order.

Why is a carton drop test part of a packaging approval?

Because a device can pass every bench check and still arrive in a crushed box. Carton dimensions, board grade, inner fit and drop behaviour decide whether the retail pack survives the journey, and they also set freight cost. Approve the packed unit, not the loose device.

What makes an inspection standard usable by a third party?

Measurements with tolerances rather than adjectives, a named reference sample, the acceptance level, and a rule for what happens on failure. An inspector who has to call the buyer to interpret the document will make the decision themselves instead. Write it so a stranger can apply it without asking.

Which document catches material substitution?

The written specification with its approved component list, checked against the bill of materials and the signed sample. A swapped cell, connector or resin can look identical while the test report on file no longer describes the product. Ask which named alternatives are permitted and require a written notice before any change.

What does a deposit and balance split actually protect?

It keeps part of the money tied to evidence rather than to a promise. A 30/70 structure means the larger payment falls due only after production, so the buyer still has leverage when an inspection says no. It does not make the deposit safe; it limits how much is exposed before any unit exists.

Is escrow or a letter of credit a substitute for inspection?

No. Both decide who holds the money and on which documents it is released; neither says whether the goods are right. An escrow release against a supplier photograph is the same unprotected wire with extra paperwork. Name the inspection report as the release document, and commission the inspection yourself.

Why compare landed unit cost instead of the ex-works price?

Because two quotes with the same factory price can differ once packaging, carton size, freight, duty, insurance and inspection are added. Asking every supplier for the same shipping term and the same packaging assumptions makes the numbers comparable. A DDP quote puts all of it in one column.

Why ask for the reorder MOQ after tooling before paying for the tool?

Because the first minimum pays for setup and the second one does not. If the reorder floor stays high after the tool is amortised, the buyer has financed an asset that does not lower the next order. Ask for both numbers in the brief and put the second one in writing with the tooling agreement.

Is Dragon Skin silicone body safe for a product I sell?

Not as a category claim, and this is the question that gets a brand into trouble fastest. Dragon Skin is a platinum-cure silicone made for special effects and prosthetics; the material family is the same one body-safe products use, but a body-safe claim depends on the full formulation, the cure, the pigment and the post-cure, not on the trade name.

Three things to ask for before it goes near a finished product: the technical data sheet from the maker, the cure ratio actually run on the line, and a finished-article test report rather than a raw-material one. A supplier who answers "it is platinum silicone, so it is body safe" has answered a different question. The material class is described in the Wikipedia entry "Silicone".

What decibel figure should a quiet massager quote, and at what distance?

One figure is not a measurement, it is a claim. A decibel number means nothing until it names the meter, the distance and the room: a calibrated meter at 30 cm in a quiet room is the convention this site measures under, and the same device reads several decibels lower at one metre. Two consequences for a spec sheet.

Ask for the distance with the number, because 35 dB at 30 cm and 35 dB at 1 m are different products. And ask for the ambient floor, because a meter cannot read below the room it sits in, so a 28 dB claim made in a 32 dB room is a claim about the room. The unit is explained in the Wikipedia entry "Decibel".

Why does platinum-cure silicone cost more than peroxide-cure?

Because the cure is a different chemistry with a different bill. Peroxide cure is a free-radical reaction that leaves by-products the manufacturer has to drive off, it cannot be safely cast against some mould materials, and it is harder to control batch to batch. Platinum cure is an addition reaction: no by-product, tighter dimensional control, and the ability to cure deeply in a closed mould, which is what makes a seamless, fully enclosing surface possible at all. The premium is in the platinum catalyst itself and in the tighter process window, not in marketing. The chemistry is outlined in the Wikipedia entry "Silicone" under the curing section.

Who is named as the responsible person on a CE declaration of conformity?

The entity that puts the product on the EU market under its own name — which, for a private-label brand, is you and not the factory. This is the single most common document defect in the category: the factory issues a declaration naming itself, the brand ships the goods, and the declaration then describes a different economic operator than the one a market surveillance authority will look for. Ask for a draft declaration with your legal entity, your address and your contact details in the responsible-person field before the artwork is signed off, and keep the technical file that backs it. The marking itself is described in the Wikipedia entry "CE marking".

What does low-MOQ customisation actually exclude?

It excludes the three things that carry the setup cost: a new mould, a new colour compound and a new print run. A low minimum is real when the offer is an existing platform plus your logo, an existing colourway and a stock box or a digitally printed label. It stops being real the moment the shape changes, because tooling is amortised over the order and 300 units will never amortise a mould, and it stops again at the packaging, because a custom box has its own print minimum that is often several times the unit order. Ask which of the three is included and which is quoted separately, in writing, before treating the number as a minimum order.

Does GDPR apply to a small adult-brand store outside the EU?

It applies to the customer, not to your address. Two triggers reach a non-EU seller: offering goods or services to people in the EU, and monitoring their behaviour — which a standard analytics and retargeting stack already does. In practice that means a lawful basis for the email list, a privacy notice that names it, a processor agreement with every tool that touches customer data, and a deletion path that actually deletes. The category adds one more: order history and purchase data are sensitive in the ordinary sense, so a breach is a reputational event before it is a legal one. The regulation is described in the Wikipedia entry "General Data Protection Regulation".

What separates a couple device from a solo device on a spec sheet?

Two things a spec sheet can actually show: whether the controls can be operated at arm length while the device stays in place, and whether the shape is neutral enough to be used from more than one side. A solo device optimises for one hand and one angle, so the buttons sit where the holding hand already is and the profile is asymmetric.

A device built for two has to survive a second person reaching for it mid-use, which means a control you can find without looking, a shape that does not dictate who is where, and a noise floor low enough that adding a second person does not add a reason to stop. Everything else on such a page is marketing.

Who keeps the technical file after the order ships?

The responsible person, for ten years after the last unit is placed on the market, and that file has to be producible on request rather than reassembled. It is the one deliverable in the whole project that a factory has no reason to keep for you: it describes your product under your name, and the factory may well have made a near-identical file for a different brand.

Ask for a complete copy at handover, in a form you can store, not a portal login that expires with the account manager. Then check that it contains the test reports by article rather than by material, the risk assessment, and the label artwork as shipped. A file that takes three weeks to obtain from a supplier is a file you do not have.

The next stage

The number you defend depends on where you are allowed to sell it.

A landed cost is only a margin once a channel will list the product, take the payment and keep the account open. The platform gate, the processor reserve and the clinical buyer each change the arithmetic on this page.