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

§00 — Technical file index Decatur, TN 37322

Medical device · Regulatory · Software UI

Your device manual, submission-ready in twelve languages.

Instructions for use, regulatory submissions and interface strings, translated for manufacturers entering the EU and Latin America. A second certified linguist reviews every file before it leaves the office on Lamontville Road. Then we send one invoice.

Send the source files or call (805) 427-0080

Read twice. Once by the translator, once by a reviewer who did not translate it.

Based
Decatur, TN
Markets
EU & Latin America
Billing
Per project, after review
Long-exposure photo of a medical device assembly corridor with soft light trails left by moving carts
Fig. 00 — In transit

§01 — Packages, priced per language

Priced per project. Invoiced after the second linguist signs.

Three kinds of file account for nearly all of our work. Each price below is per target language and includes review, formatting back into your original file type, and a signed certificate of accuracy. Send a word count and you get a fixed figure by 4pm the next weekday.

An instructions-for-use booklet with pages blurred mid-turn and a violet light trail across it
Pkg. A
Usual first project

Instructions for Use & labeling

From $1,140per language · up to 4,000 source words
  • IFU, carton text, device labels and the symbols glossary, checked against ISO 15223-1
  • Returned as InDesign, FrameMaker or Word — whichever you sent
  • Seven working days per language, typical; languages run side by side

Above 4,000 words: $0.27 per source word. Sentences already in your translation memory: $0.08.

Quote an IFU
Regulatory binders on a steel shelf, one being pulled out in a soft motion blur
Pkg. B
For notified bodies & ANVISA

Regulatory submission sets

From $3,860per language · up to 12,000 source words
  • SSCPs, clinical evaluation summaries, PMS reports and technical documentation excerpts
  • Terminology locked to your earlier submissions, so “sterile barrier” stays one phrase across years
  • Written answers to regulator wording queries for 12 months, at no charge

Larger dossiers are quoted section by section, so you can see which part costs what.

Quote a submission
A medical device touchscreen with violet light trails left by a swiping finger
Pkg. C
Per release

Software & interface strings

From $2,375per release, per language · up to 6,500 words of strings
  • .xliff, .json, .strings, .resx and .po files, placeholders and variables left untouched
  • Length checked against your pixel limits; we flag every string that will not fit the button
  • In-context screenshot review and one round of fixes after your build

Point releases under 500 changed words: a flat $385 per language.

Quote a release
$0.27per source word beyond any package limit
$165per language to typeset a Greek or Czech PDF from your source layout
$95per certificate of accuracy reissued for an additional regulator

§02 — Figures

Four numbers that describe how a file moves through this office.

Target languages
12

From German to Greek. The full list, with its quirks, is in §04.

Linguists per file
2

Both certified. The second one did not write the translation she is reading.

Invoice per project
1

Issued after review. Not per page, not per hour, not in instalments.

Working days
7

Typical for a 4,000-word IFU into one language. Eleven more take the same seven.

A reviewer's hand marking a printed translated manual, its motion caught as a soft light trail

A dosage is never rounded. A unit is never converted unless you ask in writing. A warning is never shortened to fit the box.”

House style guide, rule 1 of 41

§03 — Inbound / returned

Two folders: the one you send, and the one that comes back signed.

Folder A — what you send

Whatever you already have.

  1. Editable source files.InDesign packages, FrameMaker books, Word, XLIFF, string files. A PDF alone works, but costs a re-typesetting fee.
  2. Anything translated before.Old manuals, a glossary from 2019, a translation memory export. We would rather match it than overwrite it.
  3. The markets and the date.Which countries, which regulator, and the day your notified body or ANVISA reviewer expects it.

Folder B — what comes back

The same files, in twelve languages, signed.

  1. A fixed quote by 4pm the next weekday.It does not change unless your word count does.
  2. Translation by a native linguistwith medical device experience in that language and that market.
  3. Independent review by a second certified linguistagainst the source, our style guide and your glossary.
  4. Files in their original format,a certificate of accuracy per language, and the updated translation memory. The memory is yours. Then the invoice.

§03.1 — Questions

Questions procurement usually forwards to us.

If yours is not here, it is probably answered faster on the phone: (805) 427-0080, weekdays 9am–4pm.

Q.01Do you use machine translation?

On IFUs and regulatory submissions, no. On software strings, only if you ask for it in writing as a draft — and a translator and a reviewer still read every segment before it ships.

Q.02Who are the linguists?

Native speakers of the target language holding professional translation certification, each with medical device subject experience. The reviewer on your file is always a different person from the translator, and we tell you both names on the certificate.

Q.03Our manual is 22,000 words. What does that cost?

An IFU package covers the first 4,000 words for $1,140; the remaining 18,000 run at $0.27 per word, minus whatever already sits in your translation memory at $0.08. Send the file and you will have the exact number by 4pm the next weekday.

Q.04What happens if a regulator questions a phrase?

Forward the query. We answer it in writing, with the reasoning and any source references, at no charge for 12 months after delivery. If the regulator was right, we fix every file that uses that phrase.

Q.05Will you sign our NDA?

Yes. Attach it to the first email with the files. If you don’t have one, ours is two pages long and we will send it before you send anything.

Q.06Can you work inside our translation management system?

If it is Trados, memoQ, Phrase or XTM, yes, with a login you provide. Anything else, we export and re-import the XLIFF and check the round trip before delivery.

§04 — The register

The twelve, in the order clients usually ask for them.

Each language has one detail that catches manufacturers out. We list it here so it does not catch you.

Long-exposure night view of a highway interchange with light trails splitting into separate ramps
One source file. Twelve exits. Each one checked before it merges.

  1. German

    de-DE · de-AT · de-CHGermany, Austria, Switzerland

    The Swiss file replaces every ß with ss. We do this on purpose, and we note it on the certificate.

  2. French

    fr-FR · fr-BEFrance, Belgium

    A non-breaking space before every colon and question mark. Every one.

  3. Italian

    it-ITItaly

    Dates as 18/10/2026. Measurements left exactly as your engineers wrote them.

  4. Spanish — Spain

    es-ESSpain

    Usted throughout. Patients are not addressed as tú in an IFU.

  5. Spanish — Latin America

    es-MX · es-CO · es-ARMexico, Colombia, Argentina

    One neutral file, reviewed with COFEPRIS, INVIMA and ANMAT readers in mind.

  6. Portuguese — Brazil

    pt-BRBrazil

    Formatted for ANVISA labeling. Decimal comma. The screen is a “tela.”

  7. Portuguese — Portugal

    pt-PTPortugal

    Not a copy of the Brazilian file. Here the screen is an “ecrã.”

  8. Dutch

    nl-NL · nl-BENetherlands, Flanders

    Labels shipping to Belgium get a Flemish read before they go.

  9. Polish

    pl-PLPoland

    Seven grammatical cases. Allow extra width on buttons; we will tell you which ones.

  10. Swedish

    sv-SESweden

    Compound nouns. Some will not fit a 120-pixel button, and we will not abbreviate a warning to make them.

  11. Czech

    cs-CZCzechia

    Háčeks checked against your embedded font before we call the PDF finished.

  12. Greek

    el-GRGreece, Cyprus

    A different alphabet, so we check that the printed PDF renders it — not just the Word file.

§05 — Start a file

Lamontville Road answers weekdays, 9 to 4.

Email is fastest for quotes. The phone is better when your launch date moved this morning.

Panel 1 — The first email

What to attach, so the quote is right the first time.

  1. Editable source files, not only the PDF.
  2. The target languages and the countries they are for.
  3. Any glossary, earlier translation or memory export.
  4. Your deadline, and who reads the file at the other end.
Dusk on a rural East Tennessee road, a passing car drawn as violet light ribbons

Panel 2 — Or leave the details here

Tell us the device, the markets and the date.

Replies come from info@hollingsworthvance.com within one working day.

A small translation office with printed manuals, a figure moving across the room as a soft blur

Office, the only one

2900 Lamontville Rd
Decatur, TN 37322
Plot a route to the pin on Lamontville Rd

Panel 3 — Hours & payment

Open weekdays. Paid once, after review.

Office hours
Monday – Friday9:00am – 4:00pm
SaturdayClosed
SundayClosed
(805) 427-0080 info@hollingsworthvance.com

Invoices settle by ACH transfer or card.

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