Specialist translation services
Home Medical devicesSpecialist translations for IFUs, labeling, technical documentation, and medical software.
01 / the challenge
Medical device manufacturers need translations that preserve technical meaning, use appropriate terminology, and communicate essential information clearly to healthcare professionals and patients.
vertaalkabaal! provides specialist translation services for medical device documentation across languages and markets, with particular attention to the linguistic requirements of European market access.
From individual instructions for use to extensive multilingual documentation projects, we help manufacturers manage medical device content accurately and consistently.
Medical device translation goes beyond the accurate conversion of words from one language into another.
An instruction must describe the intended action correctly. A warning must preserve its meaning and level of urgency. A technical term must remain consistent across the IFU, labeling, software interface, and supporting documentation.
The challenge becomes greater when the same product is marketed in multiple countries, with different languages, terminology conventions, and national requirements.
Our approach focuses on the factors that matter most:
02 / document types
We translate instructions for use for medical devices, including operating instructions, installation guidance, maintenance procedures, safety information, contraindications, precautions, and warnings.
We pay particular attention to technical terminology, consistency, and clarity for the intended user.
We also support electronic IFU content and subsequent document revisions.
Product labels and packaging often contain safety-critical information within strict space and formatting constraints.
We translate labeling content, packaging text, warnings, precautions, and other relevant product information while respecting the terminology and layout requirements established for the project.
Medical device documentation may require the accurate translation of highly specialized technical, clinical, and regulatory terminology.
We support translation projects involving technical documentation, product specifications, clinical evaluation materials, risk management documentation, declarations, and other device-related records.
The manufacturer remains responsible for determining the documentation required for regulatory compliance and approving its final content.
We support the translation of clinical evaluation reports and related materials, post-market clinical follow-up documentation, summaries of safety and clinical performance, and other relevant clinical and safety information.
Our translation approach aims to preserve the meaning of clinical findings, technical descriptions, and safety-related terminology.
Medical devices increasingly rely on software, digital interfaces, and connected applications.
We translate interface strings, alerts, error messages, operating instructions, and related software documentation.
Where required, our workflows can incorporate structured localization files, terminology references, character limitations, and in-context linguistic review.
We also support manufacturers of in vitro diagnostic devices with translations of IFUs, labeling, instructions for specimen handling, technical documentation, and user-facing information.
For IVD projects, we take account of the specialized terminology and intended users of the diagnostic product.
03 / Regulatory context
The European Union's Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 establish requirements concerning the information manufacturers provide with their devices.
Language requirements are an important part of this framework. Individual EU Member States may specify the languages required or accepted for different categories of device information.
These considerations can extend beyond printed instructions and labeling to other forms of user-facing content.
For manufacturers supplying multiple European markets, consistent terminology and controlled multilingual documentation are therefore particularly important.
vertaalkabaal! supports manufacturers by translating their approved source content and applying the agreed terminology and linguistic quality procedures.
We can work with your regulatory affairs and quality assurance teams to align translation requirements with your internal documentation processes.
Translation is one part of a broader regulatory process. Responsibility for regulatory interpretation, conformity assessment, and final approval of product documentation remains with the manufacturer and its designated specialists.
Our role is to provide the linguistic expertise and project coordination needed to support that process.
04 / our quality approach
Medical device translation projects often involve multiple interrelated documents, frequent updates, and complex product terminology.
We establish a workflow appropriate to the project and its associated risks.
Each language is assigned to a professional translator with relevant technical or medical subject-matter expertise.
For medical device documentation, we can arrange independent revision by a second specialist linguist to check the translation against the source.
We work with approved glossaries, product terminology, internal reference documents, and translation memories to support consistency across documents and languages.
When source documents are revised, existing translation resources can be used to identify previously translated material and maintain consistency in updated versions.
Depending on the project, our checks can cover completeness, terminology, numerical values, units of measurement, references, formatting, and other relevant linguistic or structural elements.
We can incorporate feedback from your regulatory affairs, technical, and local market teams into subsequent revisions and terminology resources.
05 / multilingual projects
Managing a single medical device translation is one challenge. Coordinating a device portfolio across numerous markets adds further complexity.
We help manufacturers organize multilingual translation projects through centralized project management and specialist linguistic teams.
Our workflows can accommodate:
Whether you're planning an initial multilingual launch or maintaining an established portfolio, we can adapt the workflow to your documentation requirements.
06 / project scenarios
A manufacturer requires a set of instructions for use in several European languages.
We establish the target-language teams, incorporate approved terminology, coordinate translation and revision, and deliver the localized documents for the manufacturer's internal approval.
A manufacturer updates warnings, instructions, or packaging information across multiple products and markets.
We work from the revised source material and available translation resources to manage the necessary linguistic updates consistently.
A medical technology company is preparing a software release for international users.
We coordinate the translation of interface strings and supporting content, taking account of technical context, terminology, and any agreed user-interface constraints.
A manufacturer regularly updates technical documentation and customer-facing materials.
We can establish a repeatable workflow with designated project management, terminology resources, and specialist linguists to support future updates.
These are typical project scenarios, not customer case studies.
07 / faq
Yes. We support multilingual IFU projects and can coordinate the required target languages. Manufacturers should confirm the applicable national language requirements for their specific devices and intended markets.
Yes. We translate medical device and IVD documentation used in regulatory and quality management workflows. We do not replace the manufacturer's regulatory affairs function or certify a device's compliance.
We use available client glossaries, approved terminology, reference materials, and translation memories. These resources can be maintained and updated across recurring projects.
Yes. We can support content intended for printed or electronic instructions for use, subject to the source format and agreed delivery requirements.
We support standard document formats and various technical or structured content formats. We review the files before confirming the scope and method of delivery.
Ideally, we need the source documents, source and target languages, desired deadline, file formats, and any specific review or terminology requirements.
If the documents are not yet finalized, we can discuss an estimate based on the information available.
08 / final cta
From IFUs and labeling to technical documentation and medical software, our team can help you organize a specialist translation project tailored to your products and target markets.
Request a Medical Device Translation QuoteLet’s talk about your project
Email our team with your business contact details, source and target languages, type of content, project requirements, and preferred deadline.
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vertaalkabaal!Please do not include patient information or medical records in your initial inquiry. We can discuss an appropriate workflow for confidential documents.
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