Medical devices are tools and equipment used in healthcare and are often exported from their country of origin to other parts of the world. To ensure that doctors and other users can operate these devices safely, it’s crucial that they understand the accompanying documentation, such as instructions for use. This is where clear communication becomes vital, as the manual instructions, product descriptions, and packaging labels act as the bridge between the medical device companies and the users.
People in different parts of the world speak and understand different languages. This language gap could result in dangerous outcomes for patients. This is where medical translation plays a crucial role in bridging the gap between medical device companies and users from various linguistic backgrounds.
For every piece of information provided with medical devices, accurate medical document translation is essential to ensure these devices are used safely and correctly. Medical device companies must rely on medical device translation agencies to guarantee that their user manuals and related documents meet the highest standards of clarity, precision, and compliance.
These medical translation services ensure that every document whether it’s a user manual, regulatory submission, or product instruction is translated by experts with a deep understanding of the medical field. Their team of specialized translators helps companies meet strict regulatory requirements and avoid the risks associated with poor translations.
Let’s explore why translation is critical for patient safety, the severe consequences of poor translations, and how companies specializing in document translation services lead the way in providing accurate medical translations.
Why translation in product descriptions, user manuals, and packaging labels is crucial for patient safety
Healthcare professionals need to be fully informed about the devices they use, and patients need to understand the devices used in their treatment.
Medical devices are designed to improve patient outcomes, but their benefits can be lost if the accompanying user manuals, product descriptions, and labels aren’t properly localized.
To achieve this, the materials that accompany medical devices such as packaging, leaflets, marketing materials, and technical information need to be accessible. Medical device translation ensures that, whether a company is exporting to one country or many, the equipment can be used safely and effectively. Translation agencies excel in providing medical translation services, ensuring that every word in these manuals is translated by localization experts with the utmost care, as even a small misinterpretation can lead to serious errors. Whether it’s the medical document translation of technical specifications or patient instructions, accurate translation ensures users operate the device safely and according to the guidelines.
By relying on translation agencies, medical device companies can ensure that their products meet local linguistic and cultural standards, minimizing the risk of user errors and maximizing patient safety.
The risks of poor translations in the medical device industry
The consequences of poorly translated medical device documents can be severe. Regulatory bodies such as the FDA in the United States and the EMA in Europe demand absolute accuracy. Mistranslations can result in legal disputes and even life threatening situations.
For example, between 2004 and 2005, a hospital in eastern France experienced a tragic situation where cancer patients undergoing treatment were overdosed with radiation, leading to several deaths and numerous patients being harmed. Upon investigation, it was discovered that among other issues, a mistranslation contributed to the problem. The user manual was in English and had not been properly localized into French, and the hospital’s administration relied on bilingual staff to interpret the manual for dosage calculations. (Source via: Researchgate.com)
This tragedy underscores the importance of proper translations provided by medical device translation agencies tailored specifically for the medical device industry. These certified translators possess subject matter expertise and work with project managers to ensure every medical document translation is performed with technical precision. This reduces the risk of life-threatening mistakes and ensures medical devices are used correctly, no matter where they are sold.
Why companies prefer medical device translation agencies over freelance translators
One key reason medical device companies choose medical translation services over freelancers is the team of certified experts with deep industry knowledge. Certified translators ensure all documents meet the rigorous standards of global regulatory bodies.
When a medical device company prepares to launch in a new market, it must translate user manuals, packaging, and regulatory submissions into multiple languages. Working with medical device translation agencies not only guarantees accurate medical document translation but also helps companies remain compliant with regional regulations.
As per EU MDR, certified translations by an ISO 17100 certified agency are required to clear the device for sale in Europe.
By offering comprehensive document translation services, these agencies ensure that companies can confidently market their products worldwide.
Conclusion
From ensuring that patients use devices correctly to meeting regulatory demands, medical translation services play a critical role in the safe global distribution of medical devices.
Partnering with medical device translation agencies ensures that your product reaches diverse markets safely, your user manuals are precise, and healthcare workers and patients can trust the devices they depend on.
Published by: Nelly Chavez
