The medical device industry includes manufacturers who produce an extensive range of products, from surgical equipment to X-ray devices to dental hygienist supplies, all with the purpose of serving people with a variety of healthcare needs. This is an industry that will continue to grow as it serves needs all over the world and is said to grow to $384 billion worldwide next year (Source: PlasticsToday)
The medical device industry as we know it requires proper communication of contents and more to its users, handlers and distributors. Exporting medical products into new markets is a way for businesses to continue to grow. Needless to say, marketing medical devices across countries requires careful translation of all instructions and specifications while taking to account cultural differences. This leads to country-specific challenges with various regulation standards in place. For example, in Canada, firms must adhere to various French translation guidelines, the Official Mexican Norms require translation of labels and information to Spanish, Anvisa dictates the translation norms for the Brazilian market, and the European Medical Device Directive (MDD) governs the regulations for translation requirements for all member countries. The recent Brexit has had all industries guessing on what’s next in this region. UK being the major market for all medical device manufacturers (with a total healthcare spend of $252 billion), the unpredictability and instability has left many looking for other markets and production centres which will mean an increase in need for localization. On the other hand, the UK is likely to aim for mutual recognition in negotiations with the EU and this will mean that European medical device regulation will apply to the UK.
Irrespective of the target country, to ensure the various regulatory standards are met, there is a need for full traceability in every step of the translation process. One wrong move, and the firm will need to pay repercussions in the form of product delays leading to profit delays, legal battles, product seizure or recalls. To avoid these pitfalls and meet the high quality standards in the industry, all while ensuring a consistent brand image across countries, one requires an experienced translation partner. What sets the right translation partner apart?
- The right team: A team of medical translators and editors with impeccable linguistic skills, technical writing expertise, and professional degrees major areas of life sciences, biomedical engineering and medicine.
- Quality standards and traceability: It is of high importance that a medical translator has the same quality standards as the medical device firm. Do not forget to check for ISO certifications. The right partner will provide you with content that ensures the best in quality with 100% accuracy as per the regulations.
- Personalized solutions: While some translation companies give you what you want, there are a few that will provide you with the solutions that you need. These are the solutions that best suit your requirements with an efficient simplified process in place.
- Cost-effective: The best translation partners will help you cuts translation costs while helping you enter new markets. They will provide you with a simplified yet highly efficient process which will consist of creating terminology files, leveraging costs with bidirectional translation memories and much more.
In an industry as strictly governed as the medical device industry, what one needs is speed, quality and value. Translation companies need to be geared up to support the fast-changing requirements of the medical device industry. And the right company will help medical device firms through new processes and help us gain efficiencies continuously while providing high-quality translations consistently.