American Language Services has been helping medical device manufacturers expand their reach for over 35 years. In that time, we’ve developed a deep understanding of the industry and its translation needs. So deep is our dedication that we have become a well know specialist in the specific area. We have dedicated ourselves to learn the nuances and latest information to excel in this important industry. In fact, we are ISO 13485 certified each year, many years running, which is testament to our dedication to the medical device industry. This is in addition to our ISO 9001 Certification we have had also earned for many years. Working in more than 150 different languages, our linguistic experts are here to make sure you get the translation you need, are timely and accurate every time.
Below we will outline some tips that will help you prepare your documents for translation and discuss why it’s so important to have a language service provider that truly understands the medical device industry.
An Overview of the Medical Device Industry
A medical device can be defined broadly as any item used for the cure, mitigation, treatment, prevention, or diagnosis of disease. Any items that are metabolized by the body–such as pills or vitamins–are exempted from this definition. The flexibility of this definition means that this vertical includes everything from surgical gloves to MRI machines and artificial joints. This industry is an important part of the world’s healthcare systems and plays an essential role in medical innovation.
Estimating the size of the industry is difficult due to the breadth of products that lie within it. Experts estimate, however, that medical devices account for between four and six percent of the US’s annual healthcare spending. Large manufacturers in this field include Medtronic, Johnson & Johnson, GE Healthcare, and Abbott. To protect their market share, many medical device companies rely on patents.
Why Companies Like Yours Need Translation
Ninety percent of medical device manufacturers say that their need for professional translations will increase in the next five years. There are three main reasons for this:
- Most Countries Require It: The US, EU, and other governmental bodies have strict requirements for medical device marketing and manufacturing. As a condition of entering the market, most medical products undergo a stringent review. To get through that process, they need to be available in a nation’s given tongue. The tightness of the regulations depends on the risk the item poses to human health. Heart valves are much more closely monitored than surgical gloves, for instance. Sixty-five percent of manufacturers cite this regulatory oversight as a
- International Markets are Key to Success: To truly make it big, medical device companies have to expand beyond their country of origin. Globalization is so important that more than half of medical device revenues come from international markets. To do it right, you need to hire a professional translation agency.
- The Wrong Word Can Kill Somebody: Though it might be all right to hire a cheap, inexperienced translator to handle your blog, the same thing can’t be said for medical devices. In some cases, a bad calculation or poorly translated sentence can kill someone. That’s why it’s vital to get a company with infield expertise and an ISO 13485 Certification.
Commonly Translated Medical Device Documents
- Device Training Manuals
- Instructions for Use (IFU)
- Technical Marketing Files
- Labels and Packaging
- Regulatory Submission Dossiers
- Package Inserts
- Declarations of Conformity
- Medical Device Marketing Materials
9 Questions You Need to Answer Before Getting Your Content Translated
The path towards medical device translation starts with advanced planning and careful preparation. To start, ask yourself the following questions:
- Is My Content Written with Translation in Mind: Before sending your patents or labels out for translating, you have to make sure they’re error-free and watertight in their original language. You also need to double check that your sentences are simple and free of cultural references
- Does Your Current Format Allow for Text Expansion: The length and size of your content can vary widely based on the languages chosen. Be sure that you create your manuals and medical device inserts with this principle in mind.
- What Exactly Needs to Be Translated: Before starting the project, you need to decide what’ll be included. Be careful to gather everything you need before submitting the job. Forgetting your software interface, for example, can lead to overruns and delivery delays. At a minimum, anything safety-related should be included.
- Is My Source File Editable: While PDFs are nice, they’re not easy for translators to use. Make sure that the documents you supply use common formats, image types, and free of copy written information. This will make analyzing the documents easier.
- Does My Document Have a Glossary: If your medical device documentation doesn’t come with a glossary, it’s time to write one. This not only helps healthcare providers to understand your device but also helps contextualize things for your translator.
- What Type of Translator Should I Use: There are a handful of ways to get your document from one language into another. First, you can rely on in house translators to get the job done. While this ensures you have a subject matter expert, it requires you to increase your payroll every time you expand. Alternatively, you can hire a freelancer with medical experience. Though this is cheaper than the other options, it’s much harder to regulate. Furthermore, some countries require certifications that it’s almost impossible for a single person to obtain. The last way—and our obvious favorite—is hiring a full-scale translation agency to oversee your medical device translations. In the end, this is the best and most cost-effective way to get you access to a large pool of language talent in many languages, computer translation tools, and a well-defined and consistent process. This simply gives you the best end result.
- Is My Translator ISO Certified: As mentioned earlier, there are a lot of requirements surrounding documentation for medical devices. Many of these rules extend to how things are written and translated. That’s why it’s important to hire a firm that truly understands the industry and its varied market requirements. One of the best signs that you’re in the right place is an ISO 13485 certification.
- Who Will Perform the Final Review: Before any solid language agency submits their final translation to you, they should always get another set of eyes, via a professional language editor, on your medical device documentation. This person should be experienced in this specific industry and are responsible for ensuring that the terms and text used are accurate, culturally acceptable and are following current medical trends and technology.
- How Will You Manage Product Updates: Though the lion’s share of the work is already done, you’ll probably have to make changes in the future. Be sure to ask your translator resource how they process and price incremental updates. If you don’t get a clear answer, it might be a good idea to go with another
About American Language Services
Since its founding in 1985, our company has grown from a one-woman shop into a leading agency in the medical device translation industry. We are one of the largest, most successful language service providers, not just in the U.S., but worldwide. Our language experts provide a full range of language services in over 200 languages. We’re also ISO 13485 certified. Most importantly, we’re available 24 hours a day, 7 days a week.
AML-Global possesses some of the most impressive linguistic talents in the world. These highly skilled language professionals are recruited, screened, and tested to ensure high-quality work. Our stringent hiring requirements ensure that you’ll get the health expertise you need for your translation project.
By paying meticulous attention to detail, AML-Global has earned an outstanding reputation for providing cost-effective, high quality and seamless language services.
Contact us by email at email@example.com or via phone at 1-800-951-5020 for a free estimate on your medical device translation.