Certified translation · medical devices, regulatory files & software

bring us the file you’re worried about.

Name: Whitcombe & Hale
Address: 2900 Lamontville Rd, Decatur, TN, 37322, US
Telephone: (805) 427-0080

We translate device manuals, regulatory submissions and software screens into Spanish, German, Japanese and Portuguese. Your key terms get locked in a glossary before page one, and a reviewer who lives in the target country reads every line before it reaches you.

A printed medical device manual with multilingual warning text on a reviewer’s desk, a sterile instrument pouch and a pencil beside it, in black and white

book a free 20-minute call or ring us at (805) 427-0080

Who calls us: medical device makers, regulatory affairs consultants and software teams getting ready to sell into Spain, Latin America, Germany, Japan, Brazil and Portugal.

First call free, no files needed
Written quote within one business day
Signed certificate of accuracy with every delivery

do not reuseNo reutilizarNicht wiederverwenden再使用禁止Não reutilizar sterileEstérilSteril滅菌済みEstéril cautionPrecauciónVorsicht注意Cuidado use-by dateFecha de caducidadVerwendbar bis使用期限Data de validade consult instructions for useConsulte las instrucciones de usoGebrauchsanweisung beachten取扱説明書を参照Consultar as instruções de uso

What we translate

the documents that can’t afford a typo

Three kinds of work, all of them read by someone who needs to get it right the first time — a nurse, an auditor, a person tapping a screen. Each is priced per project, so you know the full cost before we begin.

IFU-0412Rev. C · p. 7

Caution: single use only.

ENDo not reuse. Do not resterilize.

ESNo reutilizar. No reesterilizar.

DENicht wiederverwenden. Nicht resterilisieren.

JA再使用禁止。再滅菌禁止。

PTNão reutilizar. Não reesterilizar.

01 · Device manuals, IFUs & labels

manuals a nurse can follow at 3 a.m.

Instructions for use, operator manuals, labels and packaging inserts for Class I–III devices. We work inside your InDesign, FrameMaker or Word files, keep ISO 15223 symbols where they belong, and hand back print-ready pages that look like your English edition.

Warnings matched word-for-word to your glossary
Layout checked page by page after typesetting

from $0.27 per word · a 40-page IFU usually lands between $1,640 and $4,900 per language

quote my manual

02 · Regulatory submissions

submissions that read like they were written there

Technical files, clinical evaluation summaries, labelling sections and responses to reviewer questions. We read the whole package before we price it, flag anything unclear in the English first, and deliver with a signed certificate of accuracy your regulator can file.

Terminology aligned with each regulator’s own wording
Version log kept for every file we touch

from $2,350 per submission · fixed price, quoted after we’ve read it

send us the outline

03 · Software & device interfaces

screens where every button still fits

UI strings, error messages, on-device screens and help text — sent as .xliff, .json, .strings or a plain spreadsheet. We check each label against the real space on screen and tell you which ones won’t fit before your developers build.

Placeholders and variables left exactly as you wrote them
Updates priced on new strings only

from $0.21 per word · screenshot fit-check $385 per language

price my string file

A note from the founders

why we stopped at four languages

Plenty of agencies will happily say yes to sixty languages. We say yes to Spanish, German, Japanese and Portuguese — because those are the ones where we know every reviewer by name, know which regulator reads the file, and can answer your questions ourselves instead of forwarding them.

4languages.
that’s the whole list.

We work out of Decatur, TN, by appointment. One project lead carries your file from the first call to the signed certificate, so you always know who to email. And if a deadline isn’t realistic, you’ll hear it from us on day one — not the night before your submission is due.

— whitcombe & haleDecatur, TN

How a project runs

what happens after you hit send

Six milestones, always in this order. Everything sits inside one per-project price, so the number on your quote is the number on your invoice.

01
a short call
Twenty minutes. Tell us what the document is, who’ll read it and when it’s due. You don’t need to send anything yet.
free
02
a written quote
One fixed price per project, broken down by language and by step. Nothing is billed by the hour unless you ask for it.
within 1 business day
03
your glossary
Before translating, we agree how your device names, warnings and button labels read in each language — then lock them.
$685 per language · up to 300 termsadd a glossary
04
the translation
A medical or software specialist works from the glossary, directly inside your layout or string files.
$0.21–$0.27 per word
05
in-country review
A second linguist living in the target market reads every line against your English and against what local users expect.
$540 per document setadd a review
06
delivery
Print-ready or build-ready files, your updated glossary and a signed certificate of accuracy. Fixing our own mistakes never costs you.
certificate included

Scroll sideways, use the arrows, or tab into the track and use your arrow keys.

The four languages

four languages, four sets of house rules

Each language has its own traps. Here’s what we watch for, so you don’t have to.

Spanish

one language, two audiences

Spain and Latin America share a language but not always a vocabulary. We ask which markets you’re entering, then tell you plainly whether one neutral version will do or whether a patient in Mexico City and a clinician in Seville need separate files.

AEMPS labellingCOFEPRIS dossiersNeutral or regional

German

longer words, tighter boxes

German strings usually run longer than English, and compound nouns don’t break politely. We measure labels against your actual screens and panels, and suggest shorter, still-correct wording before anything gets truncated.

EU MDR filesde-DE · de-AT · de-CHFit-checked UI

Japanese

politeness has a setting

A device screen, a patient leaflet and a PMDA dossier each call for a different level of formality. We choose that register with you once, write it into your glossary, and keep it steady across every file and every update.

PMDA applicationsRegister set in glossaryFull-width punctuation

Portuguese

brazil isn’t portugal

An ANVISA registration needs Brazilian Portuguese; INFARMED reads European Portuguese. Spelling, terms and even dates differ. We never swap one for the other to save time, and we’ll tell you up front if you need both.

ANVISA registrationsINFARMED labellingpt-BR · pt-PT

Before you book

the four things people ask first

Q.01

is it certified?

Yes. Every delivery includes a signed certificate of accuracy naming the translator, the reviewer, the languages and the file versions.

Q.02

how long will it take?

A 40-page IFU in one language typically takes 8–10 business days, review included. Tight deadline? Say so on the call — we’ll be honest about what’s doable.

Q.03

what if my team disagrees?

Your in-market colleague’s preference goes into the glossary and we update every instance. If the error was ours, the fix is free.

Q.04

do I need a glossary?

If the document will ever be revised, yes. It keeps “catheter hub” the same on page 3 and page 300, and makes every future update quicker to check.

book your free call

Leave your details and a line about the project. We’ll reply with a few call times — and, if you like, a secure upload link for your files.