IFUs

5 Best Practices To Translate The Medical Devices IFUs

Medical translation is one of the most complex and demanding translation fields. Doing it right is imperative to save lives and people. The medical industry and devices are one of the largest and most popular industries. It keeps on witnessing new technologies every now and then. The technology is also contributing to the development of high-quality tech medical devices, including surgical robots and high-tech nanotechnology applications. The global medical device size now is expected to stand at around US$671.49 billion by the year 2027.

As the medical industry grows, there are more medical devices and a global need for medical translation with other main equipment of the medical industry. Psychology translation is also one of these. With people addressing mental health issues openly and discussing their psychic nature people have started consulting psychologists too. Likewise, the medical device and equipment industry has also flourished like never before. There is a huge demand for the supply all over the world. This surge in demand makes it evident to hire professional translation services.

Why do we require translation of IFU documents?

The future of the medical industry and medical devices is very bright and promising. However, a problem that occurs often is the regulatory requirements. These regulations keep on changing and often make it tough for the manufacturers and people involved to keep track.

In order to facilitate people all over the world, it is mandatory to translate the content well and localize it as per the requirements and choices of the targeted region. For that purpose, it is evident to go through the whole process in the best way possible. Medical companies usually do not consider medical device documentation initially and often think it through once they decide to enter a foreign market. This approach could delay the whole process. Therefore, it is important to start working on the process of translation and regulatory translate right from the start.

Here are a few best practices to consider while executing the translation process of IFU of medical devices and equipment.

  1. Offering clear and precise instructions

For the translation of medical device IFUs, the foremost practice should be working on clear and precise instruction. Moreover, if you have gone through the navigation of the American food and Drug application process, you get to know that you could have to face additional regulatory affairs when it is to medical device approvals. Therefore, a good medical device document can help you ace through to overcome all these hurdles.

Working on a clear, concise, precise, and accurate document for the medical device IFU is one of the important components that help streamline the process. During this process, it is also recommended to keep the costs as low as possible. The list of language requirements of the European Union is there as an example which can help tell how following simple rules of clear and precise translation can make companies avoid many additional hassles and complications.

  1. Making use of reliable medical writing technique

Medical content, the manuals of medical devices, and regulatory compliance translation, all of these are technical and complex tasks. Therefore, while dealing with this content clarity should be there. You need to make sure that you place acronyms that vary from language to language along with abbreviations are there placed accordingly. Also, you should avoid unnecessary complex terms and idioms as most of these do not go well in translation into another language. You should also ensure that there is no slang in the source content. Try to use simple language and the document should comply with the directive of the medical device. It might help get a CE mark too.

  1. Working with human translators 

Though machine translation has been widely used for the translation of medical and psychology translation services. However, when it comes to healthcare and medical devices the companies and owners cannot afford mistakes and mistranslations. Translation errors can ruin the whole company and tarnish the image and financial health of an organization. This is what makes it evident that you always for an ISO-certified medical translation company. You should hire a translation company that has a competent and experienced team of human translation with relevant medical expertise.

Experienced translators understand the responsibilities that come with medical content and instructions for user manuals. They make sure there are no errors and they should also have professional project managers on their side to help through the process.

  1. Clear healthcare labeling 

Healthcare content has to undergo a lot of approvals. Also when it goes for import it has to go under a lot of regulatory matters. This is why regulatory translation also becomes a significant part of the translation of medical device documents and instructions for use.

Also, there should be clear and precise instructions for the device labels. So that users can read and understand clearly at first glance. Moreover, well-known symbols should be used on the packaging. Using international signs of caution such as manufacturer, handling with care biological risk, and a lot more. Integrating the translation with the symbols device labels and instructions can fetch more attention which decreases the risk of danger. Additionally, these take less space as compared to the text.

  1. Stay up to date with international medical device documentation

This practice is extremely important. Make sure you keep on reading the regulatory matters, rules and regulations along with the new changes in the medical industry which could be important for the translation of medical documentation of the devices. The medical industry is huge and massive and hence, national regulators often keep on altering and updating local regulations. They do this to cope with the new technologies.

Conclusion

Translating IFU often seems easy but is a complex task. The source document has to be good for an accurate and precise translation. Likewise, companies should follow certain practices for the quality translation of manuals and IFUs. These may include working on precise content, using a reliable medical technique, working with experienced human translators, and putting clear healthcare labels.