How to negotiate a translation quote for your instructions for use (IFU)

Requesting a translation quote for instructions for use (IFU) is not a mere administrative formality. For a medical device manufacturer, this quote has implications for the budget, market launch timeline and, above all, the quality of a document that supports the safe use of the device.

The challenge, therefore, is to negotiate without reducing the service to a simple price per word. An instructions for use (IFU) document contains warnings, units of measurement, cross-references, operating procedures and, in some cases, market-specific regulatory requirements. Regulation (EU) 2017/745 on medical devices highlights the importance of the information supplied with the device, while the European Commission describes the role of EUDAMED in improving the traceability and transparency of medical devices across the EU.

The objective is not to drive costs down as far as possible, but to obtain a clear quote that can be justified internally and is consistent with your quality obligations.

Translation quote for instructions for use (IFU): what affects the price

The price of an IFU translation depends first and foremost on the actual volume to be handled. Word count remains a key factor, but it is not the only one. An IFU intended for lay users will generally require particular attention to clarity, consistency of warnings and readability.

The source file format also influences the quote. A clean, finalised and well-structured Word file is generally less costly to process than a non-editable PDF, a complex InDesign file or an IFU extracted from a document management system with no clear segmentation.

Finally, the level of service also matters. A simple translation does not offer the same level of service as a process that includes translation, revision by a second linguist, quality assurance, terminology management and delivery in a format ready for integration. The ISO 17100 standard for translation services defines requirements relating to the processes, resources and aspects needed to provide a quality translation service.

Prepare your brief before negotiating

A successful negotiation begins before you send the files. The more detailed your brief, the more realistic a quote the translation agency can provide. Conversely, a vague brief may force the provider to build in contingency margins.

Before requesting a quote, prepare the following information: source language and target languages, countries where the device will be marketed, exact version of the IFU, source file format, required delivery format, word count, desired deadline, whether a translation memory and an approved glossary are available, previously translated versions and specific regulatory requirements.

The principle is straightforward: a translation agency cannot accurately estimate a project without the information needed to define its scope. AbroadLink’s article on the information needed to prepare a translation quote explains why factors such as the language combination, the type of content, the file format and supporting information all affect the quote.

This is also the time to clarify the scope of the project. Consider whether you need translation only, or whether you also require independent revision, desktop publishing (DTP), verification of units of measurement, checks of internal cross-references or alignment with your product labelling.

What you can negotiate without taking risks

The best negotiating lever is rarely a lower rate per word. For an IFU, it is often more effective to negotiate the approach, file preparation and the reuse of existing content.

For example, you can request a translation memory analysis. If previous versions of your IFUs have already been translated, identical or similar segments can be reused, revised or charged at a reduced rate.

You can also negotiate to combine several projects. If several IFUs, labels or quick guides share common terminology, handling them as a single project can reduce management costs, improve consistency and limit repetitive exchanges.

Turnaround time is another useful negotiating lever. Urgent projects require additional resources, sometimes involving several linguists working in parallel, which may result in an additional charge.

Finally, you can also negotiate file preparation costs. If you provide a final, editable and consistent source file, you can avoid unnecessary processing. This approach is consistent with the best practices outlined in our article on reducing IFU translation costs, notably the standardisation of source content and the use of translation memories.

What must never be compromised in regulatory translation

Certain items in the quote should not be removed without careful consideration. Specialised revision, for example, may seem like an optional cost from a budgeting perspective. However, for an IFU, it plays a vital role in identifying terminological inconsistencies, dosage errors, ambiguities and discrepancies between language versions.

Terminology is also critical. A validated glossary may represent an initial investment, but it helps ensure the consistency of future translations.

Traceability is another aspect that should never be overlooked. For regulatory documentation, you should be able to identify who carried out the translation, who performed the revision, which document versions were used and how changes were incorporated. ISO 17100 is a useful reference for defining the requirements related to professional translation services.

Reducing the price by removing these steps can create the illusion of cost savings. An error in an IFU can lead to internal review cycles, document reformatting, launch delays or additional questions during a documentation review.

How to compare several IFU quotes

Comparing three quotes solely on the basis of the total amount is risky. You must check what each proposal actually includes. One quote may seem more expensive because it includes revision, DTP, translation memory analysis, terminology management and final quality control. Another may seem more competitive, but exclude those same elements.

Ask for a clear breakdown of the quote, including translation, revision, project management, DTP, quality control, glossary creation or updates, analysis of repetitions and any applicable rush fees. This level of detail allows you to discuss each item without compromising the overall quality of the service.

Make sure your assumptions are correct as well. Is the quote based on final files? Does it include updates following internal validation? What happens if the IFU changes once the project is under way? Does the quote include discounts for repeated content? Are fuzzy translation memory matches charged at a different rate?

For a medical device, the translation agency also needs to understand your documentation environment. Medical device translation involves more than simply conveying the meaning of a text in another language. It must ensure consistency across the intended purpose, warnings, instructions and regulatory requirements in the target market.

Questions to ask before accepting the quote

Before approving a quote, ask specific questions. They will help you establish whether the provider genuinely understands the IFU context.

Ask who will be involved in the project: a specialist translator, an independent reviser, a project manager and a DTP specialist. Also ask which tools will be used for translation memory, terminology management and quality control.

Ask the provider how they handle version control. IFUs often changes following quality, regulatory or clinical feedback.

Finally, ask how market-specific requirements in the EU will be handled. The European Commission provides guidance on the responsibilities of different medical device economic operators, including manufacturers, authorised representatives, importers and distributors, under the MDR and IVDR.

If your project also involves broader medical content, such as patient information leaflets, clinical documents or materials for healthcare professionals, a medical translation service can complement IFU translation with suitable healthcare expertise.

When to call on a specialist company

A multilingual IFU requires coordination, control and forward planning. A specialist translation company can help you structure the project before translation even begins by analysing the files, identifying repetitions, preparing translation memories, selecting the appropriate quality workflow and providing a realistic timescale.

This is particularly useful if you work with several European languages or have frequent updates. The same applies if your documents combine instructions for use, labelling, a quick guide and supporting materials. MDR language requirements vary by Member State and depend on the type of information provided to users or patients.

In this context, IFU translation should not be treated as a standalone service. It is part of a documentation system in which consistency, readability and reusability are essential.

Conclusion: negotiate the quote, not the quality

Negotiating an IFU translation quote means finding the right balance between budget, turnaround time, regulatory compliance and document security. Price matters, of course, but it needs to be considered alongside the services included, the linguists' specialist expertise, the revision process, traceability and terminology management.

To get a better quote, prepare clean files, provide your previous translations, request a translation memory analysis, group your requirements together and plan ahead for turnaround times. That said, avoid cutting out any of the steps that ensure the quality of the finished translation.

A good IFU translation quote does not just state a price. It explains how your document will be translated, checked and delivered to support your regulatory and commercial strategy.