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Medical devices · Regulatory submissions · Software UI — 12 languages — Decatur, TN

§S — Schedule of services Billed after review

Services & rates — per target language

Your files come back in the format you sent, signed in every language you ordered.

Three packages cover almost everything a device manufacturer sends us: the instructions for use, the regulatory submission, and the software. Each is priced per target language, includes a second certified linguist’s review, and is invoiced once — after that review, not before it.

Send a word count or call (805) 427-0080
Quote by
4pm, next weekday
Readers
2 per file
Invoices
1 per project
Flat-lay of a device instructions booklet, a sterile carton and a printed string file, crossed by a violet light trail

Schedule of services

Per language

A–C are starting prices. The per-word lines that follow them are on the spec sheets below, in the row marked “Beyond.”

§01 — The three packages

Three spec sheets, each with a row for what is not included.

Read the “Not included” row first. It is the one people usually ask about after the invoice, and we would rather you read it now, on a Sunday, than in March.

Usual first project

Instructions for Use & labeling

From $1,140per language · up to 4,000 source words
Quote an IFU
Covers
The IFU, quick-reference guides, carton and pouch text, device labels, the symbols glossary, and the patient implant card if your device has one.
Send us
InDesign (packaged or .idml), FrameMaker books, Word, or the XLIFF your content system exports. A PDF on its own works; Greek and Czech then carry a $165 typesetting line.
Included
  • Translation by a native linguist with device experience in that market
  • Independent review by a second certified linguist
  • Every symbol and its explanatory text checked against ISO 15223-1
  • The file rebuilt in its original format and a printed PDF proof read on paper
  • A certificate of accuracy naming both linguists, plus your updated translation memory
Turnaround
Seven working days for 4,000 words. Languages run side by side, so twelve languages also take seven.
Beyond
$0.27 per new source word above 4,000. $0.08 per word already in your translation memory, and for sentences repeated inside the same file.
Not included
Back-translation (on the rate card at $0.19 per word). Printing. Changing the English — if the source says 37 °C on page 4 and 36 °C on page 19, we flag it and wait for you.

The carton is the shortest file and has the least room. We check fit against your dieline before it goes to the printer, not after the first pallet.

Notified bodies & ANVISA

Regulatory submission sets

From $3,860per language · up to 12,000 source words
Quote a submission
Covers
Summaries of safety and clinical performance, clinical evaluation summaries, PMS reports and PSURs, technical documentation excerpts, and the declaration of conformity.
Written for
EU notified bodies under MDR, and ANVISA, COFEPRIS, INVIMA and ANMAT in Latin America. Tell us which reader; the certificate is addressed to them.
Included
  • Terminology locked to your earlier submissions, so “sterile barrier” is the same phrase in 2026 as in 2022
  • A translator with clinical or regulatory background in that language
  • Second-linguist review against source, glossary and house style guide
  • Written answers to regulator wording queries for 12 months, at $0
Turnaround
Around eleven working days per language for 12,000 words. Scheduled backwards from your filing date, which you give us in the first email.
Beyond
Quoted section by section at $0.27 per new word and $0.08 per memory match, one line per section, so you can see that the clinical summary costs more than the declaration.
Not included
Authoring or editing your source. If the English says “may” where your risk file says “must,” we point to it. We do not rewrite it.

The SSCP has a patient version. It is written for a reading age, not for a notified body, and it is translated for the same reading age.

Per release

Software & interface strings

From $2,375per release, per language · up to 6,500 words of strings
Quote a release
Covers
Device touchscreens, companion apps, clinician dashboards, onboarding screens, and every alarm and error message.
File types
.xliff, .json, .strings, .stringsdict, .resx, .po and Android .xml. Placeholders such as {0}, %1$s and <b> stay exactly where your developer put them.
Included
  • Translation and independent review, alarm text first
  • Length checked against your pixel or character limits; each overflow flagged with a shorter option
  • In-context review from your screenshots
  • One round of fixes after your localized build
Turnaround
Six working days for 6,500 words. Point releases under 500 changed words, two.
Beyond
$0.27 per new word above 6,500; $0.08 per memory match. Point releases under 500 changed words: a flat $385 per language.
Not included
Changes to your build. We send the string; your developer moves the button. Shortening an alarm or warning to fit — we will not offer one.

“Occlusion detected” is two words in English and five in Polish. We tell you which screens that matters on before your designer finds out.

§02 — Rate card

Smaller jobs, and the one line that costs nothing.

Label updates, glossaries, back-translations. Most of these arrive between larger projects and are billed the same way: once, after review, on the same kind of invoice.

Rate card for smaller translation jobs, per unit
JobUnitPriceWhen it comes up
Label-only updateUnder 300 changed wordsper language$245A new UDI line, a revised storage temperature, one changed warning on the carton.
Software point releaseUnder 500 changed wordsper language$385Version 4.2.1, where the only change is the alarm volume screen.
Glossary buildFrom your existing documentsper language$640Before a first IFU, if you have past translations but no termbase.
Memory alignmentOld translations, up to 30,000 wordsper language$520Your previous agency kept the translation memory. You kept the PDFs.
Back-translationRisk-critical text onlyper source word$0.19Your risk file wants evidence that a warning means the same thing in Polish as in English.
Greek or Czech typesettingFrom your source layoutper language$165You only have a PDF, and the PDF has no editable text.
Certificate reissueFor an additional regulatorper certificate$95One Spanish file, filed in Mexico and then in Colombia.
Five-day deliveryInstead of sevenon the project total+22%The launch date moved this morning. Available on IFUs up to 6,000 words.
Regulator wording queriesWritten answers, with references12 months after delivery$0A notified body questions one phrase in your German IFU in month nine.

The last line is printed as $0 so that you know it exists. It appears on every quote.

A loupe magnifying Czech diacritics on a printed manual page, a violet pen beside a hand-drawn margin mark

§02.1 — Not on the schedule

Six things we will tell you, on the first call, to take elsewhere.

Saying no early is cheaper for both of us than saying it after a quote. Each of these needs a different specialist, and you deserve the right one.

  • Contracts and distributor agreements.Anything a court might read belongs with a legal translator.
  • Brochures and slogans.A tagline needs a copywriter in that country. A warning needs us.
  • Sworn or court-certified translation.Ours is a certificate of accuracy, not a sworn translator’s seal.
  • Interpreting at audits and site visits.We read. We do not speak on your behalf in the room.
  • Japanese, Chinese, Korean, Arabic, Hebrew.Twelve languages, and these are not among them.
  • Linguistic validation of patient questionnaires.Cognitive debriefing means patient interviews in each country. It is a different field.

§03 — An example quote, annotated

What a 22,000-word manual into two languages actually costs.

This is the format your quote arrives in. The device and the word count are an example; every rate on it is the published one from this page. Our notes are in the margin, in italics, where yours would go.

Quotation Q-2026-1018

Example · published rates
Prepared
18 October 2026
Valid for
60 days
File
IFU, Class IIa infusion set
Targets
pt-BR · es-LA

Sent by 4pm on the weekday after your word count arrived.

IFU package, pt-BRFirst 4,000 source words, review and certificate included1 × $1,140$1,140
New words beyond package, pt-BRWords not in your translation memory15,000 × $0.27$4,050

18,000 words over the package. 3,000 of them were already in the memory you sent.

Translation-memory matches, pt-BRChecked in context, billed at the memory rate3,000 × $0.08$240

This line is why we ask for your old translations. It saved $570 per language.

Same three lines, es-LANeutral Latin American Spanish, one file1 × $5,430$5,430

Translated at the same time as pt-BR. Seven working days total, not fourteen.

Certificate reissue, INVIMA and ANMATCOFEPRIS certificate included above2 × $95$190

One translation, three regulators. You pay for the paperwork, not the words twice.

Regulator wording queriesBoth languages, 12 months from delivery12 months$0
Total, both languages $11,050

Invoiced once, after the second linguist signs both files. Settled by ACH, Visa, Mastercard or Amex.

The invoice says this number. It arrives after review, not before.

§04 — The calendar, for a 4,000-word IFU

Seven working days, from the approval email to the signed files.

Every language on the order follows this calendar at the same time. The dates assume you approved the quote on a Wednesday, which is the most common day for it.

Example: quote approved Wednesday 21 October 2026, files delivered Thursday 29 October 2026.

  1. 1Wed
    21 Oct

    Terminology first.

    Your glossary and old translations are matched against the new file. Any term with two candidate translations goes to you in one email, not six.

  2. 2Thu
    22 Oct

    Translation starts.

    A native linguist works through the file in Trados or memoQ with your memory loaded. Symbols are checked against ISO 15223-1 as they appear.

  3. 3Fri
    23 Oct

    Body text finished.

    By 4pm. Warnings, contraindications and dosing tables are reread by the translator before the file leaves her desk.

  4. Sat–Sun
    24–25 Oct

    Office closed.

    The file waits on Lamontville Road. It does not move on its own.

  5. 4Mon
    26 Oct

    Handed to the reviewer.

    A second certified linguist, who has not seen the file, reads it against the English segment by segment.

  6. 5Tue
    27 Oct

    Marks resolved.

    Translator and reviewer settle every mark. Disagreements go to the house style guide; rule 1 usually decides it.

  7. 6Wed
    28 Oct

    Rebuilt and proofed.

    Back into InDesign or FrameMaker. The PDF is printed and every diacritic, line break and table is checked on paper.

  8. 7Thu
    29 Oct

    Delivered, then invoiced.

    Files, a certificate of accuracy per language, and your updated memory by 4pm. The invoice follows the same afternoon.