Download Medical Device and Biotechnology Translation: Client Stories (PDF)
Bubbles Translation Services
The Sector
Medical device and biotechnology translation is not a specialism you arrive at casually. It finds you, or rather, the consequences of getting it wrong find you.
Under EU MDR 2017/745, medical device documentation must be available in the official language of each member state where the device is placed on the market. For manufacturers distributing across the EU, that means up to 24 languages. Instructions for Use, labelling, Summaries of Safety and Clinical Performance, EU Declarations of Conformity — all of it, in every required language, before the product can legally reach a patient or clinician.
The document types span a wide range. IFUs for complex diagnostic equipment. Patient information leaflets written for people who have no medical training and may be frightened. Device labels where a 12-word English warning becomes 17 words in German but the physical label has not grown by a single millimetre. Safety Data Sheets with 16 mandatory sections. Clinical data summaries that must balance scientific precision with regulatory clarity. Packaging text for products shipped in sterile barrier systems where reprinting is not a minor cost.
A translation error in a marketing brochure is embarrassing. A translation error in a patient-facing document or a device label is a safety risk. The distinction matters.
In our project data, safety and SDS documentation accounts for 1.4% of all projects by volume. That sounds modest until you consider what those documents protect against. Biotechnology is our highest revenue sector at 9.66% of total revenue, driven by the sheer breadth of documentation that regulated life sciences companies need translated — often into many languages simultaneously, often under regulatory deadlines that do not accommodate delays.
We have been translating medical device and biotechnology documentation since 2003. Over two decades, the regulatory landscape has shifted beneath us repeatedly — from the Medical Devices Directive to EU MDR, from paper IFUs to electronic, from national approvals to centralised European frameworks. What has not changed is the fundamental requirement: accuracy, precision, and an understanding that these documents exist to protect people.
The six client stories that follow are drawn from across this sector. Each presented a different challenge. Each required a different approach. Together, they illustrate why medical and biotech translation is not simply translation with longer words.
Biogen: When the Reviewers Change the Source
Biogen develops therapies for neurological diseases, including treatments for Multiple Sclerosis that are prescribed to patients across dozens of countries. The company’s global reach means that patient-facing documentation must work in every market — not just linguistically, but in terms of comprehension. A patient newly diagnosed with MS, reading about their treatment in their own language, is not a clinical professional. They need clarity without condescension.
Bubbles was engaged to translate approximately 30 patient-facing documents into multiple international languages. The content required medical accuracy while remaining genuinely accessible — a balance that is harder to achieve than it sounds. Medical terminology that clinicians use instinctively can be opaque or alarming to patients. Every translated document had to navigate that line.
The translations were submitted to Biogen’s in-country reviewers for approval. They were accepted without changes — a result that anyone who has worked with pharmaceutical in-country review will recognise as unusual. Reviewers exist to find problems. When they find none, it means the translation understood not just the language but the regulatory and therapeutic context.
That initial project led to an ongoing engagement: lifestyle and wellbeing content for MS patients, delivered at a rate of two to five pieces per week through apps and online platforms. But it was the review process that introduced an unexpected complexity. In-country reviewers would occasionally make regulatory-required changes to the target language text — adjustments mandated by local regulatory authorities. Those changes then needed to be reflected back into the English source documentation, which meant translating from the target language back into English. Because Bubbles works exclusively with native-speaking translators for each language direction, this required assembling a different translator team for the reverse translation. It is a workflow that most agencies would not anticipate and many could not accommodate.
SureScreen Diagnostics: Speed Under Pressure
In early 2020, SureScreen Diagnostics was a UK-based diagnostics company with a solid reputation in its field and a manageable international footprint. By mid-2020, demand for rapid Covid-19 test kits had transformed the business. Export orders were arriving from countries SureScreen had never previously supplied, each requiring device inserts translated into their national language before the product could legally enter the market.
The translation challenge was not complexity alone — diagnostic test inserts are technically demanding, with precise procedural steps where ambiguity could lead to incorrect test results. The challenge was speed layered on top of complexity. New target languages were being added as fast as export agreements were signed. A test kit sitting in a warehouse because the insert had not been translated into Portuguese or Polish was a test kit not reaching the people who needed it.
Bubbles’ existing expertise in pharmaceutical and medical device translation meant the technical foundation was already in place. Translators with diagnostic device experience were already on the books. Terminology databases for medical device inserts already existed. What had to scale was capacity and responsiveness — turning around highly technical translations into a growing number of languages under timelines that would normally be considered unreasonable.
The partnership established during that period has continued as SureScreen has expanded its international operations. The crisis created the relationship. The quality sustained it.
DWK Life Sciences: Building a Terminology Foundation
DWK Life Sciences — formed from the merger of DURAN, WHEATON, and KIMBLE brands — manufactures precision laboratory glassware and equipment used in research and clinical laboratories worldwide. Their product documentation is deeply technical: specifications for volumetric tolerances, chemical resistance properties, sterilisation procedures, and material compositions. It is not content that lends itself to generalist translation.
Before engaging Bubbles in 2014, DWK (then operating as SciLabware) had struggled to obtain reliable French translations of their technical product sheets, catalogues, leaflets, labels, and website content. Previous translation agencies had not been able to handle the specialist terminology consistently. A borosilicate glass specification is not the same as a soda-lime glass specification, and the distinction matters to a laboratory purchasing manager making a decision that affects experimental validity.
The approach Bubbles took was to build the terminology infrastructure first. Working from DWK’s own approved materials — product datasheets, existing catalogues, internal reference documents — Bubbles constructed terminology databases and glossaries that captured the company’s specific usage. Not generic scientific French, but the precise terms DWK used for their products and processes. This front-loaded investment in terminology management meant that each subsequent translation project started from a consistent, validated base rather than from scratch.
The proof of concept was French. Once DWK could see that their product documentation read as though it had been written by someone who understood laboratory equipment — not merely someone who spoke French — the scope expanded. Additional European languages followed, then international languages for markets further afield. A decade on, the relationship continues, underpinned by the same terminology databases that were built in the first year and have been maintained and expanded with every project since.
Epredia: Continuity Through Corporate Change
Corporate restructuring creates particular challenges for translation suppliers. When a business unit spins off from a parent company, the new entity inherits products, people, and regulatory obligations — but supplier relationships do not always survive the transition. Procurement reviews, new vendor qualification processes, and the simple disruption of organisational change can sever partnerships that took years to build.
Epredia, a specialist in pathology and diagnostics equipment, was previously part of Thermo Fisher Scientific. Bubbles had an established relationship with Thermo Fisher, translating technical documentation for laboratory and diagnostic equipment across multiple languages. When Epredia became an independent entity, the question was whether that translation relationship would transfer or whether Epredia’s new procurement structure would require starting the vendor qualification process from zero.
The relationship continued. The technical knowledge Bubbles had accumulated through years of translating Thermo Fisher’s diagnostics documentation — familiarity with pathology workflows, histology terminology, laboratory equipment specifications — was directly relevant to Epredia’s product range. The translation memories, terminology databases, and established quality processes transferred seamlessly because the products had not changed, even if the company name on the purchase order had.
For Epredia, this meant no loss of momentum. Documentation projects continued without the ramp-up period that comes with onboarding a new translation partner. For Bubbles, it confirmed something we had observed across other client relationships: when the underlying expertise is genuine, it has a durability that outlasts corporate reorganisation.
Sea-Band: From Amazon Listings to Certified Health Translations
Sea-Band produces drug-free nausea relief products — acupressure wristbands used for travel sickness, morning sickness, and chemotherapy-related nausea. It is a product that sits at an interesting intersection: consumer goods in some markets, classified health product in others. That classification determines what kind of translation the packaging requires.
The relationship started modestly in 2013 with French translations of Amazon product listings — content delivered in CSV format for upload to Amazon’s content management system. It was straightforward e-commerce localisation work. But as Sea-Band expanded internationally — into broader European markets, then Eastern Europe, the Far East, and Arabic-speaking countries — the translation requirements evolved along with the commercial ambitions.
In markets where Sea-Band’s products are classified as health products, packaging translations must meet regulatory standards. This is not a matter of preference. A health product sold with packaging that has not been translated to the required standard cannot legally be sold. For these markets, Bubbles provides certified translations accompanied by a separate Certificate of Translation — a formal document attesting to the accuracy and completeness of the translation, signed and stamped.
The journey from Amazon CSV files to certified health product translations illustrates how a client relationship can evolve when the translation supplier understands the regulatory implications of market expansion. Sea-Band did not need to find a second supplier for their regulated markets. The same team that had been translating their consumer content understood the difference between a product listing and a health product label, and could deliver both to the appropriate standard.
FrontierMEDEX: Life-Critical Accuracy
FrontierMEDEX, a US-based company with operations valued in the billions, provides medical solutions in some of the most challenging environments on earth — conflict zones, natural disaster areas, and remote locations where conventional healthcare infrastructure does not exist. Their documentation includes first-response medical procedures used by personnel in Middle Eastern countries, where the accuracy of translated instructions is not a commercial consideration. It is a matter of life and death.
Before engaging Bubbles, FrontierMEDEX had relied on untrained local staff to translate their medical procedure documentation. The results were what you would expect when complex clinical procedures are translated by people who are bilingual but not trained translators, and who have no background in medical terminology. The risk was not hypothetical. Ambiguity in a first-response medical procedure — a drug dosage, a contraindication, a step in a surgical protocol — has consequences measured in patient outcomes, not customer complaints.
Bubbles was asked to assess the quality of the existing translations. That assessment established the extent of the problem and the case for engaging professional translators with medical specialisation. The transition was not simply a matter of retranslating existing documents. It required establishing terminology standards, building glossaries for the specific medical procedures involved, and implementing a quality assurance process appropriate for life-critical content.
The initial engagement expanded progressively. Commercial agreements, training publications, and HR materials followed. Eventually, FrontierMEDEX entrusted Bubbles with their specialist medical publications — the most sensitive and technically demanding content in their documentation portfolio. That progression from quality assessment to trusted specialist supplier was not rapid. It was earned through consistent accuracy on documentation where the margin for error was zero.
What We Have Noticed
Across two decades of medical device and biotechnology translation projects, certain patterns recur. They are worth noting because they tend to catch organisations by surprise if no one mentions them in advance.
Regulatory review adds time, and it should. In-country regulatory review of translated medical content is not a bottleneck to be eliminated. It is a necessary quality gate. The organisations that manage this well are the ones that build review time into their project plans from the outset, rather than treating it as an unwelcome addition after translation is “finished.” We always advise clients to allow for it. The ones who listen avoid the last-minute compression that creates errors.
Terminology management is the foundation. Without a maintained terminology database, every translation project starts from scratch. With one, consistency compounds over time. The difference between a first project for a new client and a fifth project for an established one is not that we work faster — it is that the terminology is settled, the style is agreed, and the translator is working from a validated base rather than making decisions in isolation. For medical content, where a single inconsistent term can trigger a regulatory query, this is not an efficiency gain. It is a compliance requirement.
Certified translations are increasingly required. Health products, medical devices, diagnostics — the trend across international markets is toward requiring formal certification of translated documentation. A Certificate of Translation is a small deliverable, but it carries legal weight. Organisations expanding into new markets should establish early whether their product classification in each territory triggers a certification requirement.
Speed matters in crisis situations. Covid-19 demonstrated this sharply, but it applies more broadly. Field Safety Corrective Actions, product recalls, urgent safety notices — these are all time-critical documents that must be translated accurately under extreme time pressure. The organisations that respond fastest are those with established translation partnerships, pre-qualified translator teams, and existing terminology databases. Building those relationships during a crisis is too late.
Patient-facing content is a different discipline. Translating a technical device specification and translating a patient information leaflet for the same device require different skills. The first demands terminological precision. The second demands terminological precision and the ability to make complex medical information genuinely accessible to a non-specialist reader. Not every medical translator can do both well. Knowing which skill set a document requires — and assigning accordingly — is part of what experienced project management looks like in this sector.
Questions about your project?
info@bubblestranslation.com | 0870 777 7750
Bubbles Translation Services — Specialist medical and biotech translation since 2003
