In this globalized world, we come across many multicultural communities that speak different languages. Therefore, communicating with them is full of challenges. These challenges can be dealt with by hiring professional translation services. The translation is very important to share the information among different cultures in their languages. One of the important fields in which translation holds significance is the medical field. Why is this field so important? This field is important because it deals with human lives.
Developed countries of the world are spending a large amount of money on medical research. This resulted in the innovation of medical devices. Of course, you want the world to take leverage from your medical devices. So here comes the requirement of medical device document translation. Such translation is very complex because it deals with strict regulations.
For example, a department of food and drug administration FDA regulated by the Center for Devices and Radiological Health uses US medical device safety regulations that are very strict. To sell medical devices globally, it is very important to follow the regulatory approval processes. Each country has its own rules and regulations. You can comply with regulatory rules only if you understand them and you can understand them by hiring a professional language partner.
Medical Device Documents that Need Translation
You have to translate many types of documents before introducing a device in a foreign country. Let’s have a look at them:
- Regulatory approval documents.
- Manuals for Physicians
- Product inserts and labeling
- Medical device interface that can be medical software
- Instruction for use of various medical devices.
- A case report from CRF
- Investigator’s brochure which is required for product study
- Informed consent form ICF required before the use of the device.
- Training material for medical staff.
Best Practices for Medical Device Document Translation
The medical device industry is growing with great speed. It is expected that by the end of 2025, the worth of this industry will be $612.7 billion. So, you can well imagine the importance of the quality translation of medical device documents. They should be accurately translated. Otherwise, it could have life-threatening consequences. Let’s have a look at best practices for medical device document translation.
Understanding the Regulatory Requirements in Advance
Before going for medical device document translation, first, determine the documents that you need to translate. Then check for which languages you have to translate the documents. Check their translation requirements. Also, make sure that there are any specific standard requirements for medical device translation like certification and back translation. All this information can help to get accurate translation results on the first attempt. You don’t need to plan the translation again. Moreover, you don’t have to rework documents. Thus, it will save you time and money.
Using Translation Memory
To use medical devices accurately, you require instructions to use IFUs. These IFUs need to be translated frequently. Therefore, to translate the same content again and again, you have to look for the translation vendor that is using translation memory. TM is a file that saves the translation in the memory.
Therefore, if you require the translation of the document again, you don’t have to translate the entire document, instead, you can use the already translated text. This will save you time and money. At present, many translation companies are using a form of TM called TMX format.
When the translation company provides you with medical device document translation then do ask them about translation memory. After having the translation memory of your medical project, you can negotiate with other translation companies to charge you affordable rates.
Translating the Device Interface
For medical device translation, you have to translate the user interface first. This should be done before the translation of IFUs. After translating the user interface, save it in the translation memory. When the user interface of the medical device is translated and approved, then translate IFU. This will keep consistency in the use of the medical device and the IFU documents. Moreover, it will also assist your technical team to prepare the screenshots that you can further use in IFUs.
Use Standard Labelling Translations
Each medical device contains some medical symbols that depict its usage or any danger associated with it. These symbols have standard meanings that are followed worldwide. Therefore, it is very important to use these standards in IFU translations. You can find these standards from medical authorities and official websites
Using an Appropriate Design
Many medical device manufacturing companies that want to tap into global markets translate the IFU, s in 20 languages. Sometimes they publish IFUs in all languages in one publication. Putting all the languages in a single publication is a difficult task. This task can become easy if you take the assistance of an experienced designer. The designer can accommodate the IFUs in different languages appropriately. You should hire a translation company that can easily translate all the languages in such a format that can easily be integrated into the IFUs. Such information like assembling the medical device and the procedure of its maintenance should be editable. If you want to add the text in graphics then the translation company can edit the graphics otherwise, it will take a lot of time.
Hire a Professional Translation Company
The medical field is very critical because any mistranslation in this field can lead to human death and legal threats. The legal threats are observed when you are unable to follow the rules and regulations about health in foreign countries. With inaccurate medical device translation, you cannot tap into foreign markets.
They will be disapproved by the legal authorities and will cost you high. Moreover, if legal formalities are not fulfilled, it will result in fines. Irrespective of the region in which you want to tap, you have to go through an approval and registration process. Therefore, to overcome all these problems you have to hire a professional translation company.
Medical translation can be tricky. The use of jargon makes it all the more difficult for translators and therefore, you need industry-specific experts for flawless results. Following the tips mentioned above can help you get the best translation for medical device documents.