Medical device translations are a critical aspect of the healthcare industry. They ensure that important information related to the use, maintenance, and safety of medical devices is available to users in different languages. However, medical device translations are typically more difficult than other types of translations because they require a high level of accuracy, precision, and technical knowledge. In this article, we will explore why medical device translators should have a scientific or technical background, along with why they must have a working knowledge of issues related to regulatory compliance, quality control procedures, risk, and liability. Without the requisite background, knowledge, and expertise, linguists can’t accurately translate what they don’t fully understand.
Why Medical Device Translations are Difficult
There are several reasons. Medical devices are highly technical products, and supporting documentation must be as precise and accurate as the devices themselves. A small mistake in the translation of a medical device instruction or warning label could have serious consequences for the patient, physician, or medical technician using the device.
Secondly, medical device translations involve complex terminology that requires a deep understanding of medical and scientific concepts. Translators who lack this understanding may not be able to accurately translate the technical terms used in medical device instructions or manuals.
Thirdly, translations must comply with regulatory requirements. These devices are regulated by various agencies, such as the Food and Drug Administration (FDA) in the United States, and must meet specific requirements for safety and effectiveness. Translations of medical device documentation must also comply with these regulatory requirements, and translators who are not familiar with these requirements may be hampered in their ability to provide accurate translations.
The Importance of Scientific or Technical Backgrounds for Translators
Given the technical nature of medical device translations, it is essential that translators have a scientific or technical background. Appropriately qualified translators will have a better grasp of the technical terminology used in documentation. They’ll also be more familiar with regulatory and compliance issues.
Translators with scientific or technical backgrounds are also better equipped to understand the context of the translation. These translations often involve very complex instructions or procedures, and translators who lack a medical or scientific background may not fully comprehend the purpose and intent of these instructions or procedures.
Regulatory Compliance in Medical Translations
Translations must comply with regulatory requirements in the country or countries where the device or devices will be used. These requirements may include specific labeling requirements, warnings, and instructions for use. It is critical that translators be familiar with these requirements to guarantee that the translations are in full compliance.
Quality Control Procedures
Quality control procedures are of the utmost importance in this area of translations if accuracy and consistency are to be maintained. At TrueLanguage, the quality control procedures we have in place for our translators are very detailed and exhaustive and include multiple rounds of review and proofreading by highly qualified reviewers, editors, and subject matter experts. These procedures help to identify errors or inconsistencies in the translation at an early stage so that the final product is accurate and consistent.
Risk and Liability
The accuracy of medical device translations is absolutely key for patient safety. Errors or inconsistencies in the translation could result in serious harm to the patient using the device. In addition, manufacturers of medical devices can be held liable for any harm caused by their products. It is therefore critical that medical device translations be accurate and consistent and comply with regulatory requirements. Only appropriately qualified translators who have due respect and a full understanding of the stakes involved can produce medical device translations that unfailingly conform to mandatory standards.
Background and Education of a Medical Device Translator
The technical nature of medical device translations requires that translators have a specific type of background and education. Ideally, a medical device translator should have a degree in a relevant field such as medicine, biology, or engineering. This will provide them with a solid foundation in the technical terminology and concepts involved in medical device translations.
In addition to a relevant degree, they should have a strong understanding of regulatory requirements. This may involve completing additional courses or training in areas such as FDA regulations, CE marking requirements, and other associated standards.
Medical device translators should also have experience working with medical device documentation and be familiar with the types of documents involved in medical device translations, such as instructions for use, labeling, and packaging.
They should likewise have a full understanding of the principles of risk management and quality assurance, especially surrounding the medical device industry. They should similarly be able to identify potential risks and address them effectively. Such capacities are absolutely essential for translations that convey the proper intent, are accurate and consistent, and are compliant with regulatory requirements.
Finally, it is of course a given that medical device translators must have strong language skills in both the source and target languages, with native fluency in the target language. This is indispensable given the existence of cultural nuances and idiomatic expressions in language in general, how much more in the field of medicine and science.
Conclusion
We hope this article gives you a newfound appreciation for medical device translators who have the aptitude, training, and skill to successfully complete these complex translations. Accuracy in medical device translations is crucial for patient safety, and linguists cannot accurately translate what they don’t fully understand.
TrueLanguage is ready and able to help with your next medical or scientific translation project. Our team has years of experience working in this industry and can bring your next project in on time and on budget.
