Medical & MedTech
Instructions for use (IFU), labelling, regulatory and QARA documentation, plus manuals and technical product documentation in the MDR/IVDR context.
Medical, MedTech, Pharma & Legal · English–German
Medical and legal translation where every word counts.
Translated for more than 150 companies since 2011 – including several world leaders in medical technology, diagnostics and pharmaceuticals.
Your advantage is a direct line: you commission the specialist translator – and the same one every time. Terminology, style requirements and approval processes are documented from previous assignments and kept up to date. Once a decision is made, it holds. Your reviewers find your requirements already applied, document after document.
— Wilhelm Lindner, specialist translator since 2011
Specialist translation in the AI era
Precision backed by personal responsibility
Machine translation can now produce fluent text. But in clinical documentation, regulatory submissions and contracts, what matters is not speed but accuracy. A mistranslated dosage instruction or an imprecise contractual term can have far-reaching consequences.
I have provided these services as Lindner Übersetzungen in Passau since 2011. I translate from English into my native German and use technology only where it is fit for purpose. I personally check and take responsibility for every sentence.
From the initial quotation to final delivery, you deal directly with me. I price the work, translate your document, answer your queries and deliver the checked German version.
The examples on this page were created solely for illustration. None contains client material or reproduces the unedited output of a particular translation system.
English source text
Do not resterilize.
Error type: lost negation
„Erneut sterilisieren.“
Meaning reversed – patient risk
Reviewed translation
„Nicht erneut sterilisieren.“
Negation retained, meaning preserved
English source text
The Supplier shall notify the Customer.
Error type: weakened modal verb
„Der Lieferant soll den Kunden benachrichtigen.“
An express obligation becomes less clear – creating interpretive risk
Reviewed translation
„Der Lieferant ist verpflichtet, den Kunden zu benachrichtigen.“
Contractually unambiguousServices
What I translate and review
For regulated and demanding content where raw machine translation is not enough.
Pharma & Authorisation
Summaries of product characteristics (SmPC), package leaflets, labelling and marketing authorisation documents – deliberately limited to this one document family.
Legal & Contracts
Contracts, terms and conditions, data protection texts, and employment, contract, EU and commercial law documents for German and international audiences.
AI Post-Editing
Expert review of machine-translated content for technical accuracy, terminology, consistency and language-related risks – performed as full post-editing in line with ISO 18587. A quality report is available on request.
For procurement and specialist teams
You have one subject-matter contact who works to your requirements – under an NDA if required and in the project environment agreed for the assignment. Terminology and quality assurance are documented. The review path is defined before the project starts and agreed with your in-house reviewers. The delivery date and fixed price are binding.
My experience with regulated documentation comes largely from years of continuous work for world-leading manufacturers.
Other subject areas by arrangement. I take on only what I can stand behind.
Machine translation is one stage of the work, not the finished text.
Why not just use DeepL or ChatGPT?
AI translates in seconds. Someone has to put their name to it.
For internal e-mails, AI tools are often sufficient. But in published, patient-facing or legally binding material, incorrect technical terms, phrasing that distorts the meaning and inconsistent terminology remain a risk. I work with these tools every day and know their strengths and blind spots.
AI is changing this profession. Where its use is appropriate for the subject matter and contractually permitted, it can accelerate individual stages of the work. I use the time saved for specialist review. Whether human translation or full post-editing is appropriate depends on the intended use and risk profile of the document.
Process
From enquiry to delivery
Enquiry
You outline your project; we agree the appropriate route for confidential documents. NDA available.
Fixed-price quote
After reviewing your material, I send a binding quote with the delivery date.
Translation
Specialist translation with terminological quality assurance; documented quality report on request.
Delivery
On time, in your chosen format; one round of corrections included.
References
Mostly regulated documentation
Since 2011 I have translated for more than 150 companies – from specialist SMEs to global corporations. This project experience spans German and Swiss companies as well as international manufacturers supplying the German-speaking market.
The core of this work is medical device documentation: instructions for use (IFU), labelling and regulatory material in the MDR/IVDR context – mainly for orthopaedic and surgical implants, in-vitro diagnostics and ophthalmology. Documents for clinical investigations and trials are another regular part of my work: protocol summaries, participant information and informed consent forms. Legal texts form a strand of their own. The companies I have translated for also include pharmaceutical and biopharmaceutical corporations.
Who commissions the work, and what it contains, remain confidential throughout; I am happy to talk you through anonymised project examples in person.
150+companies I have translated for since 2011
IFU · Labelling · Regulatorymedical device documentation focus in the MDR/IVDR context
DE · CH · AT · internationalproject experience with world-leading medical technology, diagnostics and pharmaceutical corporations
Quality & standards
Two standards, a clearly defined scope
This section sets out what is part of every project, what is agreed separately, and how the two ISO standards shape both.
DIN EN ISO 17100 – Process
Project preparation, terminology work, translation and documented self-checking follow the process steps of the standard for translation services. The revision by a second person the standard additionally requires (the four-eyes principle) is not one I perform myself: you name the reviser, from your own specialists or an outside party you appoint, and I work their feedback in. Your documents stay out of other hands. In my experience, every extra pair of hands in the chain costs terminological consistency, quality and, above all, time; on large, complex texts that can push out the delivery date and raise the cost.
ISO 18587 – Post-editing
I deliver AI post-editing as full post-editing in line with ISO 18587: the result is comparable to a human translation – not a quick read-through. I meet the standard’s qualification requirements for post-editors through my full-time professional translation practice since 2011.
Confidentiality & AI
Whether and how far AI tools are used is agreed before the project starts. AI-assisted steps have to be compatible with your requirements and confidentiality obligations. Otherwise I do not use them. On request, your project is handled entirely without AI. An NDA is available at any time.
Confidentiality follows a defined process
Client-specific reference and instruction documents remain local. Only the text excerpts required for a particular external AI-assisted step are used. Where this does not compromise the technical meaning, direct identifiers are first replaced with locally managed placeholders.
Terminology, style requirements, project-specific QA rules and mapping tables are managed locally for each client – they govern both translation and quality assurance consistently, without exposing confidential content themselves. The permitted tools and safeguards are agreed before the project starts.
I hold no ISO certificate, nor am I a publicly appointed and sworn translator; certified translations for courts and public authorities are therefore not something I offer. What I promise here, however, comes without an asterisk.
Your translator
From law to medical technology
Specialist translator since 2011
In 2011 I started out in legal translation – employment, criminal, contract, EU and commercial law. For many years, my main focus has been medicine and medical technology, from clinical studies to surgical technique guides.
I work in the agreed project environment, using translation memories, specialist glossaries and documented quality assurance. I keep terminology, style requirements and QA steps consistent throughout the assignment. I translate exclusively into my native German and personally review and take responsibility for every project.
Fees
What determines the price
Fees are calculated on a transparent basis: the subject area, volume, terminology and QA work involved, and the delivery date. The quotation confirms both the fixed price and delivery date; urgent projects are discussed in advance.