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Exporting medical devices to EU?

Medical Devices

Medical Devices

Are you looking to export medical equipment to Europe? You might not be surprised to read that exporting medical equipment is a rather complex process. And believe it or not, the translation/localization piece is the least of your worries. Why, you ask? Because EPIC Translations fully understands the requirements for medical device translations.

If you’re looking to export to Europe, then consider the following:

  • EU has 27 member countries. This list is likely to grow in the future.
  • 500 million consumers speak 22 different languages

(Un)Fortunately, all EU countries have adopted the three EU Medical Directives:

  1. Active Implantable Medical Devices (AIMD);
  2. Medical Devices (MDD);
  3. In-Vitro Diagonistic Devices (IVD).

What does this mean for medical device manufacturers? Essentially that all labels and instructions must be localized to each country BEFORE the medical devices reach the end users in all EU countries. So, if you’re looking to increase your sales and export your medical devices to Belgium; then the labels and instructions for your medical devices MUST be localized to Dutch, French, & German. For Denmark, localization must be done in Danish. For Finland, localization must be done in Finnish AND Swedish. And so forth.

Here is a complete list of the EU countries, the languages, and what exactly has to be localized:

Country Language What must be localized
Austria German AIMD, MD, IVD
Belgium Dutch, French, & German AIMD, MD, IVD
Cyprus Greek AIMD, MD, IVD
Czech Republic Czech AIMD, MD, IVD
Denmark Danish AIMD, MD, IVD
Estonia Estonian AIMD, MD, IVD
Finland Finnish, Swedish AIMD, MD, IVD
France French AIMD, MD, IVD
Germany German AIMD, MD, IVD
Greece Greek AIMD, MD, IVD
Hungary Hungarian AIMD, MD, IVD
Ireland English AIMD, MD, IVD
Italy Italian AIMD, MD, IVD
Latvia Latvian AIMD, MD, IVD
Lithuania Lithuanian AIMD, MD, IVD
Luxembourg French, German, & Liezeburgish AIMD, MD, IVD
Malta Maltese or English AIMD, MD, IVD
Netherlands Dutch AIMD, MD, IVD
Portugal Portuguese AIMD, MD, IVD
Slovenia Slovenian AIMD, MD, IVD
Spain Spanish AIMD, MD, IVD
Sweden Swedish AIMD, MD, IVD
United Kingdom English AIMD, MD, IVD

Here is a map of the EU for your reference:

EU Map

EU Map

So as you can see, exporting your medical devices to the EU is a little bit more challenging than exporting textiles or financial services. However, partnering with a Language Services Partner (LSP) that understands the rules and regulations for the medical device industry will make things much easier for you.EPIC Translations has linguists in every single country in the EU that specialize in medical devices. Thus, we can provide you with not just accurate translations, but also create a terminology database for you that will help you in your future endeavours.

Why workflow matters

Why workflow matters

Why workflow matters

Why Document Translation Workflow Matters

I’m sure you’ve heard the saying that not all cars are made the same way! Similarly, not all documents are translated the same way. The final quality of the translation is completely dependent on the type of workflow employed for your specific translation. Generally speaking, every document translation workflow should go through at least 2 linguists. But there are instances where more than 6 linguistic resources may be necessary in order to create the best possible translation of a document.

Why such a difference? I’m glad you asked! Let me explain.

A document such as a birth certificate can be accurately translated by a single well-experienced linguist with a careful review by the project manager.

A document such as a legal contract, technical manual, medical record, financial statement, adoption application, etc should never be translated by a single linguist. Instead, it should be translated by 2 linguists with a careful review the project manager.

A document such as patent application, high-level business expansion plan, and drug application should go through the back translation process which might include 5 to 6 linguists plus the project manager.

All in all, the type of workflow used for your translation will ultimately influence the quality of your translation. When you speak to your LSP, be sure to discuss your various options I’ve mentioned above.


Read: 6 Step Translation Protocol

Why select EPIC Translations as your LSP?

Select EPIC Translations As Your Language Service Provider

Remember the age-old story of the Tower of Babel? According to it, people used to speak one universal language until they were punished by suddenly speaking in different tongues. Hence, the difficulty we now have of understanding each other when each one is speaking his or her native speech. If you’ve tried going on a trip to a country where everything sounds strange, you’ll know exactly how frustrating this can sometimes be. And this is true for language both in the spoken and written form. It’s quite hard for communication to happen when you have a document in Italian and the person who is supposed to read it only knows English or Spanish.

Best Document Translation Services

Like the story mentioned above, we at EPIC Translations provide equally epic services in document translation. Our company believes that while the various languages of the world are unique in their own right, these differences should create no barrier to effective communication. To this end, we offer the best document translation services to ensure that you won’t have to struggle with attempting to read words you’re not familiar with.

EPIC Translations knows that time is no man’s friend. In this modern world where everything is fast-paced and instant gratification is the demand, we provide unparalleled translation services that meet our client’s time constraints. We know that the success of businesses hinges on certain requirements, and we are up to the task of filling them. We have consistently met deadlines set by customers and continue to give the utmost dedication to others that seek our expertise. In fact, our confidence in conveying order on time is seen in our Deadline Guarantee, an offer unique to EPIC Translations.

We have a team of highly specialized professionals to perform all language translation services of all kinds, be it for technical translation or documents in other industries. These translators have the necessary experience and skill for delivering complete and accurate content to our customers. We offer document translation in the following languages: English, Arabic, Italian, Chinese, Russian, Hindi, Thai, French, Spanish, German, Portuguese, Japanese, Korean and African languages.

Task Life Cycle

EPIC Translations uses a Task Life Cycle (TLC) in order to perform quality professional translation services. Using a 3-person team, we follow certain steps that involve project management, editing and strict proofreading to make sure that translation has been rendered well. In addition, we have an internal tracking system to monitor progress in all document translation projects, likewise allowing us to link clients and translators from different locations around the world. This system helps us to tailor-make translation services to your specifications for more effective document translation.

Knowing the value of communicating properly, we at EPIC Translations guarantee to keep you informed of how your project is going every step of the way. You can log onto our website as a customer to check on updates regarding the translation services you want us to do. Unlike other companies, you won’t have to keep wondering if your document is going to be delivered soon or continue doubting the authenticity of your translator.

EPIC Translations has been doing business with customers globally, and have a roster of contented clients who have seen first-hand what we can do. We offer our translation services at the most competitive prices in the shortest time possible and can reduce your total costs with software that creates translation memories. This means you won’t have to keep getting a certain document translated several times over. In addition, we have strict confidentiality clauses to protect your company’s privacy and document content; we never give out our customers’ information to other parties.

So come to us for your needs in translation services! We have an easy quote box for you to let us know in the quickest time just what it is you want. By filling in the form, you’ll be well on your way to receiving best document translation services that are sure to satisfy you!

Acquiring Translation Services

Acquiring Translation Services

If you have operations in multiple countries or are looking to establish operations in multiple countries then there is a strong probability that you will need to translate some of your content. You might ask yourself why do I need to take translation services seriously?

Can you imagine a foreign company expanding to the USA and not having their Marketing material in proper English? Or their Customer Service representatives not knowing the company policies? If this seems unprofessional & unprepared, then it will also be unprofessional & unprepared for your organization to expand to another country and not be able to properly communicate with your customer base in their native language. In fact, a study conducted by the independent market research firm Common Sense Advisory found that customers are 6 times more likely to buy if product information is in their native language.

Additionally, there will be a need to put the Operations pieces in place before you can start operating in a foreign country. For example, you might need legal contracts, financial documents, engineering specs, and company policy documents translated. Furthermore, it is more likely that you may need translation services on an on-going basis rather than just a one time deal.

With that in mind, there are four avenues to consider in your acquisition of translation services:

  1. Use internal employees as translators in addition to their regular job functions;
  2. Hire new employees as dedicated translators;
  3. Outsource all translation needs to a Language Services Provider (LSP);
  4. Use a hybrid approach of the 3 options

The first thing to do is to analyze and estimate your need for translation services. Historically, companies who are expanding overseas have underestimated their need and did not properly create an acquisition infrastructure for translation services. As a result, not only did they have to spend 25% to 40% more on translation services, but also had to accept the translations at a lower quality due to the fact that the content needed to be translated urgently.

Once you’ve established your level of need for translation services, the next step in the process is to decide what approach you want to use. There are pros and cons to all 4 approaches.

Using internal employees as translators in addition to their regular job functions can seem to be a very attractive option. If your translation needs are infrequent and do not require a certain background then this option might work. For example, if the employee that speaks the target language is in Finance and you need a Financial statement translated then this option might work. But it is not recommended to use the internal employee with the background in Finance to translate a Legal contract even though he/she might speak the target language. The reason being that the employee with Finance background might not be familiar with the Legal terminology. Another thing to keep in mind is that not all speakers of the target language can be translators.

Hiring new employees as dedicated translators might not be economically feasible for all companies. In addition to keeping them busy all the time, you also have the challenge of acquiring and maintaining a sustainable translation infrastructure in place. For example, having an Information Technology infrastructure for Computer Assisted Translation tool, Translation Memory, and Terminology files requires careful planning and can be quite daunting for most small to mid-sized companies.

Language Services Provider

Outsourcing all translation needs to a Language Services Provider (LSP) is an option that many companies give a serious consideration to. However, this option might not be feasible for all companies because it requires the considerable level of integration of the LSP into your documentation operations. For example, it might be worthwhile to implement translation management software to automate most of your translation needs. This will not only automate your translation services related operations but in the long run, it will also cut down your translation costs in various ways. In order to do this, you have to have a stable demand for translation services.

Using a hybrid approach of the 3 options is something that most companies that have been acquiring translation services for 2 to 3 years end up choosing because it offers the most flexibility.

It is noteworthy that if you’re just starting out in acquiring translation services, your best option is to go directly to a Language Services Provider (LSP) because you will need the experience and the quality is driven workflow of the LSP. Moreover, an LSP such as EPIC Translations, can provide multiple linguistic resources and customize a translation flow that caters to your business that yields a world-class production ready translation.

In our next white paper, we’ll go over how to select a Language Services Provider (LSP) that can adapt to you and your business needs. To automatically receive the next white paper, please subscribe to our monthly newsletter on the right side.

BRIC – where to go

Once you have decided that you want to start exporting to BRIC countries, the next step is to decide where exactly to start at! Simultaneous expansion to all 4 countries should be undertaken only if you have significant resources at hand, otherwise it’s a smarter idea to tackle one country at a time.

We tell our clients the following criteria (among other things) to use when making such a decision.

  1. If B2C, what country has most demand for my products / services?
  2. If B2B, what country has the most footprint of my clients?
  3. What country has more qualified human resources?
  4. What country has a more dependable transportation infrastructure?

It is vital that you respond to these and other questions in as much details as possible. Your responses should be based on independent market research.

At the end of the day, no mater what country you decide to expand to, having a world class translation of your content might be the deciding factor between success and failure. We tell our clients to translate the following content in order to correctly get started:

  1. Website
  2. Product / Service manuals
  3. Legal contracts
  4. Company policies

Money spent on translation services will have an immediate return on your investment as you will be able to connect with your customers / clients at a deeper and native level.

Translation Memory

Benefits Of Translation Memory

Those companies that have used translation services in the past know the benefits of translation memory. But if you’re just getting started with translating your content and are not sure how to leverage your translated content to reduce your future translation costs, you’ve come to the right place! I’ll keep this post short & sweet so you can take away the necessary information:

In the simplest form, a translation memory, or TM, is a database of sentences or paragraphs that have been previously translated. Each unit that contains source text and target text is called a segment.

“Research indicates that many companies producing multilingual documentation are using translation memory systems. Usage of TM correlated with text type characterised by technical terms and simple sentence structure (technical, to a lesser degree marketing and financial), computing skills, and repetitiveness of content.”

So, there you have it. Feel free to contact us should you have any questions as you dive into the world of translation services.

Importance of client feedback

Client Feedback

Client Feedback

When you’re doing a large project with a LSP that requires multiple linguists and your company specific terminology, the importance of providing feedback for the first few batches of files can not be over emphasized. In this scenario you should not expect total quality until at least 2 to 4 batches of files have been completed, feedback has been provided, and the linguists have had the opportunity to integrate the feedback into the current and future batches. Moreover, if you maintain your own terminology database, there might be technical issues that have to be addressed before total quality can be realized. For example, is your terminology database based on industry standards? If not then there might be a great deal of technical challenges to get thru (32 bit vs 64 bit or OS incompatibilities.)

While it is reasonable to accept total quality for the entire project, it can not be realized without giving enough time to implement your specific feedback. It is best to work with your LSP contact to ensure your feedback has been successfully integrated into the project.

Does your LSP adapt to YOU?

It’s difficult enough managing business operations in a single country let alone in multiple countries. Some of the challenges for multinational companies (MNCs) might include the shortage of qualified human resources, unfriendly business environment, conflicting interests, corruption, language barriers, and labour cost to name a few. When all of these challenges are combined together, organizations can face a great deal of uncertainty.

Reliable Language Services Provider

One area where MNCs can really benefit by having a reliable business partner is in the area of addressing language barriers. While some companies prefer to keep language services a strictly internal operation, most companies will use a hybrid approach where some of the language services are carried out internally and some are carried out externally with a reliable language services provider (LSP.)

When using an external LSP it is vital that they adapt to your needs. Business operations are never static and the information/content being localized/translated might need to be changed to reflect the dynamics of your business operations.

For example, if the source text in the product manual your LSP is translating needs to be changed for any reason, your LSP should not only be able to accommodate this change, but the change should be reflected in the terminology database and the translation memory.

Moreover, if you’ve decided to target the Canadian French market, your LSP should be able to minimize your translation costs by localizing the existing French translation for the Canadian French market instead of doing a completely new translation. In other words, your reliable language services provider should be operationally well invested in your business and your business goals.

Fast turnaround ability

Fast Turnaround Ability With Language Service Provider

Not surprisingly, more and more companies are listing “fast turnaround ability” as the most important factor when working with language service providers. Fast turnaround ability is important for some very good business reasons. For one, the global economy runs on information. And two, companies that operate globally have to deal with different time zones. And more importantly, the global economy demands it.

The ability to not only provide translations quickly but doing it with quality and having the ability to handle your increased demand are also essential.

How to Measure Language Service Provider Abilities

How can you measure these abilities when looking for a new language services provider? The answer really lies in your gut feeling based on your initial interactions with the LSP. Were they quick to respond to you? Did the responses sound professional and quality driven? Does the LSP have case studies on their website? Does the LSP have the infrastructure needed to support your needs? Another approach is to have the LSP do a short sample to test their abilities.

Most common requested languages

World Languages

World Languages

Did you know that the following 15 languages constitute 80% of global GDP?

  1. English
  2. Chinese
  3. Japanese
  4. Spanish
  5. German
  6. French
  7. Portuguese
  8. Italian
  9. Russian
  10. Arabic
  11. Hindi
  12. Korean
  13. Dutch
  14. Bengali
  15. Turkish

Now compare that with Cisco’s annual Visual Networking Index that  estimates how different countries will consume internet traffic by 2015.

Consumer Internet Traffic by 2015

Needless to say, if you’re looking to grow your company, you must be open to the idea to selling your products and services globally. If you decide to take the global route then you should also know that according to research done by Common Sense Advisory, “the vast majority (85.3%) of respondents feel that having pre-purchase in formation in their own language is a critical factor in buying insurance and financial services. Conversely, just 45.8% of the sample told us that language is important to buying clothes on the web. The more valuable an item, the more likely it is that someone will want to read about the product and buy it in their own language.” So, all in all, the language in which you sell your products and services in does matter.

Credit: Cisco, The Economist, and Common Sense Advisory.

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