Instructions for use and labelling
Across instructions for use (IFU) and labelling, I apply the terms you have approved, consistently.
Medical devices · English–German
Users, reprocessing staff and the notified body read the same German sentence.
For many years, instructions for use (IFU), labelling and regulatory documentation have remained the mainstay of my full-time work. I translate the English documentation of leading international medical device and diagnostics manufacturers into German, and review German versions that already exist.
Instructions for use are rarely read at leisure. They are consulted in the middle of a task: before a procedure, during reprocessing, in a notified body assessment. The wording therefore needs to be unambiguous in each of those situations.
Numbers, units, warnings
One character is all it takes
In medical device documentation, the errors that matter are rarely errors of style. They sit in numbers, units, negations and warnings, and they are linguistically invisible: a spellchecker finds nothing, because nothing is formally wrong. The content is wrong all the same.
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
Rinse the cannula with 1,000 mL of sterile saline.
Carried over unchanged
„Die Kanüle mit 1,000 ml steriler Kochsalzlösung spülen.“
Read as German, this is one millilitre – a thousandfold error
Reviewed translation
„Die Kanüle mit 1.000 ml steriler Kochsalzlösung spülen.“
German convention applied, quantity unchangedInconsistency costs time downstream. When labelling, instructions for use and technical documentation name the same thing differently, queries can follow and put pressure on the schedule.
So I check these documents specifically for accuracy of meaning, specialist terminology, numbers and units, warnings, clarity for the intended reader, and consistency across related documents. The reference points are the requirements of the MDR and IVDR and, where the document calls for them, the terms and symbols of DIN EN ISO 15223-1.
Regulatory responsibility remains with the manufacturer. My translation does not make a device compliant with the MDR or IVDR and does not replace conformity assessment or CE marking. What it does is render the English source accurately, in the right terminology, in German.
The standards-related requirements and steps I cover are explained on the home page under Two standards, a clearly defined scope.
Documentation focus
Instructions for use, regulatory documentation, clinical investigations, surgical technique guides
Regulatory and technical documentation
Regulatory and QARA material, including Summaries of Safety and Clinical Performance (SSCP), together with manuals and technical product documentation. I work within the documentation and review process you specify.
Clinical investigations and trials
Protocol summaries, participant information and informed consent forms. I have worked on separate consent forms for children and for adolescents, on Austrian German versions, and on a plain-language protocol summary.
Surgical technique guides
A surgical technique guide addresses the operating team and follows the procedure step by step: approach, instrumentation, implant sizes. I bring the names of instruments and components into line with the instructions for use for the same product system.
Product experience
Product areas with documented project experience
Orthopaedic and surgical implants
The largest part of this work. Instructions for use and regulatory documentation for implants, where product, use and safety statements have to hold together across product families and successive versions.
In-vitro and molecular diagnostics
The second major area. IVD documentation in which diagnostic, technical and regulatory terminology has to fit together.
Ophthalmology
Documentation for ophthalmic devices, written for the stated intended purpose and user group.
Interventional and general surgical devices
Technical and regulatory content for devices used during a procedure, where handling steps and warnings have to be clear at the point of use.
Dental products
Product and application documentation for dental implants, instruments and associated equipment.
Workflow
From context to documented decision
Clarify context
We establish the intended use and readership of the document before work starts.
Incorporate references
I bring your approved terminology, translation memory and reference material into the agreed project environment.
Translate or post-edit
I translate the document myself, or carry out the agreed full post-editing myself.
Self-check
I then check the translation for meaning, numbers, units, warnings and consistency, and document the results.
Incorporate your feedback
Where your own specialists review the translation, I incorporate their feedback and answer any queries that arise.
Record decisions
I record the decisions arising from queries and apply them to later documents where applicable.
For specialist teams and procurement
Collaboration, terminology and choice of method
Can a project be commissioned alongside an existing language service provider?
Yes. I take on clearly defined English–German content, or review a translation you already have. Either works as a self-contained assignment alongside your existing providers.
How are existing terminology, translation memories and reference material incorporated?
Your approved terminology is binding on me. I use translation memories and reference material, but I check them against the context of the document in hand. Where I find a conflict – two terms for the same thing, or an instruction the document contradicts – I raise a query rather than decide for you. The decision is recorded and applied to later documents.
Which medical and medical device documents are within scope?
The core is instructions for use (IFU) and labelling, together with regulatory and QARA documentation, including Summaries of Safety and Clinical Performance (SSCP). Alongside those: surgical technique guides, manuals, technical product documentation and product-related marketing copy. Clinical investigations and trials form a second regular strand, from the protocol summary through to the consent form. I decline documents outside my subject area.
When is human translation more suitable than full post-editing?
Intended use, risk profile and the quality of the source determine that, not the price. The more directly a text reaches users or feeds into labelling, the more likely I am to translate it from scratch. Where full post-editing holds up, I deliver it as a complete professional edit of machine-translation output as defined in ISO 18587, not a cursory read-through. I tell you which route suits your document before I quote.
Instructions for use or study material
Let’s start with one specific document
Document type, intended use, volume, file format and deadline are enough for a solid assessment. We agree the route for confidential files beforehand.