Medical device documentation translation for FDA and EU MDR

One ambiguous label or mismatched technical file can hold your device launch in the review queue. ABC translates the IFUs, labeling, clinical evaluation reports, and EU MDR submissions your reviewers read, across 120+ languages, at $0.09 per word.

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9001, 17100 certified

Certified translators

25 years of service

Trusted, private, and secure

Passes regulator review

Device documentation your reviewers can clear on the first pass

A device cannot reach a market until its documentation passes review in the regulator's language. Use instructions, labeling on the product, reports from clinical evaluation, and the filings sent to regulators all need accurate translation, and where the U.S. FDA or the EU Medical Device Regulation is involved, that frequently calls for certification.

The cost of getting it wrong is steep. An inaccurate or uncertified translation can delay an approval, create a safety risk, or get market access denied outright. For a manufacturer or distributor, that is lost revenue and a launch window that closes while a submission sits in a queue.

This is exactly what medical device translation at ABC is built for. Across more than 120 languages, we deliver certified renderings to meet global regulatory requirements, each page carrying a signed statement that vouches for accuracy and the translator's competence, with the work handled by specialists who know the subject and keep technical and safety wording precise.

Over 255,000 customers across 25 years have put their device documentation in our hands and cleared submissions with regulators the first time through, with the accurate translation that FDA, EU MDR, and other authorities require.

Precise work from native speakers

Native-speaking linguists handle every project, catching the subtle shades of meaning that keep your message accurate, clear, and true to its culture.

Quick, dependable, and protected

You get fast turnaround without any drop in quality, backed by tight confidentiality and data security from start to finish.

Support that actually helps

A responsive team stands ready at each step, so the whole process feels smooth, professional, and free of stress.

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Two routes to choose from

Certified pages for filings, an average of $0.09 per word for everything else

Certified translation is the route for filings to regulators, safety paperwork, and submissions headed to the FDA or EU MDR authorities. Standard turnaround is 48 hours, with an expedited add-on for urgent submissions, and every order includes unlimited revisions.

Professional translation at an average of $0.09 per word covers internal training materials, manuals, marketing, and other non-regulatory communications. Every certified translation tied to medical device paperwork carries our 100% acceptance guarantee on regulatory and compliance filings, which means a rejected translation gets corrected and resubmitted first, with a refund only if it keeps getting rejected after that.

Send your documentation and we will return translations built for the regulators reviewing them.

Every file handled

Commonly translated medical device documents

Bringing a device to new markets means its documentation has to satisfy the FDA, EU MDR, and other reviewers in their own language. The medical device documents we translate most often include:

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Accurate, native-language work

What makes ABC Translations the right partner for your medical device paperwork?

Accurate, native-language translations

Every linguist on our team is a seasoned native speaker, which keeps each translated file clear and precise.

Fast and reliable service

Because we know how much getting it done on time matters to you, we keep delivery fast while still holding firm on precision and careful attention.

Trusted certified translations

Every translation we deliver is certified to satisfy the criteria that most institutions and agencies around the world expect, so your process stays smooth and free of headaches.

Secure and confidential

We treat everything you send with strict confidentiality and protection, so each file stays private from translation through delivery.

Responsive customer support

From start to finish, our committed support staff stands ready to help, keeping the whole translation experience easy and worry-free.

Details & Pricing

Everything you get with certified translation from us

Each file is rendered line by line by a professional and arrives on ABC Translations letterhead, paired with a signed, stamped statement attesting that the translation is accurate. Skilled linguists produce precise, dependable work quickly, and same-day handling is available when you need it. Pricing stays transparent with nothing tacked on, and tight safeguards protect everything you share.

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Certified Translation

Strict line-by-line source-matched translation with signed certification, often for personal official purposes.

$24.10

per page

Included

Expert human translation
Revisions included
Formatting included
Digital PDF delivery
Secure & confidential
Signed & stamped certification

Available add-ons

Expedited Turnaround: We move your order to the front of the line, cutting the usual translation time roughly in half so processing speeds up and your files reach you sooner. $15.00 / page
Proofreading: Before your files go out, a second translator checks the work for precision, grammar, layout, and consistency throughout. $10.00 / page
Notarization: You receive a stamp, a signature, and a tamper-evident digital certificate that confirms the translation certification and holds good in every one of the 50 states. $20.00 / order
Apostille: This apostille confirms that the notarization is genuine so your document is recognized across nations that belong to the Hague Convention. From $80 / order
Hard copy: A physical, certified translation carrying real ink stamps and signatures, sent through FedEx so you can track it on the way. From $16.00

A simple workflow

How it works

Thanks to a simple, well-organized workflow, having your paperwork translated is fast and hassle-free.

Upload documents & place your order

Pick the two languages, send over your files, and choose any extras you want, then we get moving on your translation right away.

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Professional translation and review

Your document is translated with care by a professional linguist. Before anything is locked in, you get to look it over and ask for changes.

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Receive your translation

Once finished, the translated files are sent to you, and when you have chosen certification, a signed, stamped certificate on our letterhead comes with them.

Clear answers

Frequently Asked Questions

Find clear answers to the questions teams ask most when translating and certifying medical device records. We cover the reason certification is needed, the documents that call for translation, who is qualified to produce them, how long it takes, how revisions are managed, and the acceptance guarantee we stand behind.

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What is a certified translation?

A certified translation is a translated document that comes with a signed Certificate of Translation Accuracy. The certificate includes the translator's statement that the translation is complete and accurate, along with their credentials and contact information.

Regulators such as the FDA and EU MDR authorities require certified translations for regulatory and safety documentation.

What does a certified translation include?

Your certified translation package includes the complete translation, a signed Certificate of Translation Accuracy with the translator's credentials, and digital delivery in PDF format.

Hard copies with original signatures are available on request for an additional fee. The translation is formatted to meet the receiving regulator's requirements.

Are your translators qualified for this type of work?

Yes. Our translators are professional linguists fluent in both the source language and target language, with subject-matter knowledge that keeps technical and safety content exact across the translation.

When do device documents need a certified translation?

As a rule, anything headed to a regulator, your safety paperwork, and submissions to bodies like the FDA or the authorities behind the EU Medical Device Regulation will call for certified translation. Internal and marketing materials usually only need professional translation.

What does an uncertified or inaccurate translation risk?

It can stall approvals, create safety risks, or get market access denied. Certified, accurate translation built to each regulator's requirements is what keeps a submission moving.

How fast can you turn around a submission?

Expect a 48-hour standard turnaround, and choose the expedited option when a submission cannot wait. Unlimited revisions are included with every order.

What if a regulator does not accept the translation?

For regulatory and compliance filings, certified translations carry our 100% acceptance guarantee. If a translation is not accepted, we correct it and resubmit first, and only if it keeps getting rejected after those corrections do we refund your money.

How do we submit documentation for translation?

Upload your files through our secure online order form. We accept common document formats, and our translators begin once you submit your order, delivering within the stated turnaround time.

How much does medical device documentation translation cost?

Certified translation is priced per page for regulatory and safety filings, and professional translation averages an average of $0.09 per word for internal materials, manuals, and marketing. Expedited delivery is available for an additional fee.

Keep exploring

Related professional translation services

Other professional use cases we handle, from the filings regulators review to the labeling, IP, and IT compliance that travel with a device program.