What happens when a device, designed to save lives, fails at a critical moment? Not because of any technical malfunction, but because the person using it was not clear on the instructions.
This grave situation can become a stark reality in the global sector if some vital steps are not taken. Today’s medical technology, or MedTech, caters to a global consumer base that includes linguistically and culturally diverse customers. However, to avoid errors while using medical devices, these MedTech companies also need to ensure clear communication between themselves and their diverse customers. Without multilingualism (using multiple languages) for medical devices, errors can become common. Fortunately, professional medical device localization makes medical devices multilingual, which can avoid these errors.
In this blog, we will explore what medical device localization is and some expert tips to ensure top-notch localization services.
But before that, we need to understand the role of multilingualism in MedTech.
The Importance of Multilingualism in MedTech
Although the innovation happening in MedTech is global, its success mainly depends on its local response. For example, a company has added new features to a glucometer, but the updated instruction manual is only available in English. Would the device be highly successful in a country like Brazil or China, where English is not common?
Several contents of medical devices need to be linguistically accurate, culturally relevant, and legally compliant. Some of them are:
- Device User Manual
- Device Interface
- Product Label
- Software Strings
And the list goes on.
With assistance from medical device localization services, companies manufacturing medical devices can adapt the language, visuals, layout, symbols, and unit of measurement according to the region where it is to be distributed. Some other advantages of medical device localization include:
- Patient Safety: Keeping the patient safe is a must in the healthcare industry. By making device instruction manuals multilingual, companies can ensure the safety of the patient using the device.
- Global Market Reach: Multilingual content for medical devices also opens up the avenue of expanding overseas. For example, a medical device manufacturer aiming to enter Brazil can do so by translating and localizing its content into Brazilian Portuguese.
- Boosted Credibility: It’s not easy to trust a company that sells technical medical devices at first glance. However, a company selling its products with multilingual content can instantly win the trust of linguistically diverse customers.
- Better User Experience and Device Longevity: Multilingual content ensures an efficient use of the medical device. This improves the user experience and the longevity of the device.
How Does Medical Device Localization Help?
Companies often assume that contacting medical device translation services to translate the language of the supporting documents is enough. But that is a risky shortcut.
A translated but poorly localized user manual would not factor in cultural shifts and can result in operational errors, misuse of equipment, or even patient harm. Furthermore, by not involving certified medical translators, companies also risk facing legal penalties for not complying with local regulations.
That’s why collaborating with professional medical device localization services is the best way to ensure clarity, accuracy, and compliance in all device-supporting documents.
Want to localize a medical device effectively? Read on for some expert tips from Somya Translators.
Best Practices for Medical Device Localization
- Regulatory Adherence
Compliance in the MedTech industry is a must. Every market follows its own set of regulations, which the device manufacturers must “follow to the T.” Localization of medical devices must meet legal expectations to avoid future penalties or product bans. Some examples of such regulations are the FDA in the U.S. or the MDR in Europe. The EUMDR has a certain complex set of rules that are necessary for companies to follow. Explore more on our related blog: Medical Device Translation: Translate According to the Guidelines of EU MDR. - Specialized Terminology Management
Medical terminology used in user manuals and other documents must be completely accurate. Having a specialized glossary during translations ensures consistency across labels, documents, and software. A well-maintained translation memory also supports future updates and reduces translation costs significantly. - Human-in-the-Loop Translation
Although machine translations have evolved rapidly, they should still not be the only reliable tool for translating. Human expertise and oversight in editing are vital for these complex documents. Only certified medical translators understand the complex medical language and can proofread and edit translated content properly. - Multilingual Desktop Publishing (DTP)
Translating documents like a leaflet needs visual tweaks. Changing the language can also affect the layout of the document. For example, an ultrasound machine designed for the Saudi Arabian market needs all documents to be converted into Arabic. But as Arabic is a right-to-left (RTL) language, multilingual DTP is necessary for documents to remain visually accurate and professional. - Software and UI Localization
Not just printed materials, but devices that contain a digital interface or apps also need to be translated and localized. For example, a blood glucose monitoring device needs healthcare software localization for features such as start test, check level, date/time format, and measurement units. - Proofread, Review, and QA
All localized content must undergo linguistic, technical, and regulatory review. This includes end-user testing, which validates the medical device before market release.
Case Study: While Entering the Korean Market
South Korea is a global hub for selling medical devices; however, entering the market is complicated.
Any medical device entering South Korea needs to follow these four steps:
- Registration with the Ministry of Food and Drug Safety (MFDS).
- Classify themselves into one of four risk classes (I-IV).
- Comply with the rules of Korean Good Manufacturing Practice (KGMP) standards.
- Appointment of a Korean medical license holder.
So, when a European MedTech company planned to launch a Class II device in South Korea, they decided to collaborate with a professional medical device localization company. By translating product details and user manuals into Korean and making them compliant with local laws, the company was able to acquire a selling license from MFDS.
After clearing regulatory and linguistic hurdles, the company was able to sell its device in South Korean hospitals while raking in significant revenue and profits.
The Perfect Medical Device Localization Service
When looking for a medical device localization service, there are some vital considerations:
- The company needs to have expert experience in the medical industry.
- Translation must be done by native and medical specialist translators.
- The company must be certified under ISO 17100 for translation quality, ISO 13485 for medical device quality management, and ISO 9001 for standard quality.
- Offering comprehensive services like healthcare software localization and clinical trial translation services is a must.
- A quick turnaround time with affordable costs is always appreciated.
Somya Translators, a leading medical device localization service provider, ensures that MedTech companies across the globe can offer compliant, clear, and linguistically accurate content. As a globally trusted medical device localization company, we deliver top-notch results in over 170 languages.
With certified medical translators, we understand the depth of regulatory, cultural, and linguistic accuracy that a medical device demands.
Whether you are launching in Europe, Asia, or Latin America, we help you overcome complex regulatory and linguistic challenges with precision.
When the language of healthcare is global, why stop your medical device at just one language?
Contact Somya Translators today for top-notch medical device localization services.
Reach out to us via call (+91-11-43061918) or email (info@somyatrans.com).
Or visit our website: https://www.somyatrans.com/services/.
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