Medical Devices Translations
FAQ
Pharmaceutical translations – Medical devices translations – Clinical research and trials translations
FAQ
Translating medical device content is no easy task, requiring thorough preparation both before and during the project.
When dealing with the medical device industry, language service providers need to follow strict standards and guidelines throughout the translation process. Even the most minor inconsistency or mistranslation could have dire consequences when entering global markets.
The European conformity mark, or CE marking, is essential if manufacturers are to sell their products in member states of the European Union. Any mistake could lead to a failed conformity assessment, meaning the product would not receive the CE marking.
With translation bearing such great responsibility in the outcome of conformity assessments, manufacturers and other professionals need to choose their translation provider carefully. However, medical device translation also requires extra preparation in the preliminary stages, before even considering which translation provider to use.
By following these 5 tips, you can prepare your medical device documents for translation and give yourself the best chances of receiving a quality translation.
1.Define the documents and file formats
Medical device documents cover a broad range of specific documents, including information for use, marketing materials, and software or hardware manuals. These all come in different file formats and have different user interfaces, which means that each type of document requires a different approach to translation.You need to be clear and precise about the exact nature of your documents when making a translation request. That way, your translation company will be able to deliver high-quality work that meets the requirements of both you and the authorities.
Before assigning the translation project to an agency, make sure to clearly define the type of documents and content to be translated, as well as the file format.
2.Adapt the content to your target audience
When it comes to translating medical documents, make sure the content is adapted to your target audience. Your texts must comply with the local regulations and laws currently in effect in the country you wish to target.If these regulations are ignored, then you will be unable to sell your products legally within your target market. Make sure the documents you submit to your chosen translation agency are accurate and law compliant. This will give you the best chances of receiving a quality translation that will allow you to expand into your chosen market.
It is also important to clearly define your target audience, as this will also influence the language requirements. Two countries can speak the same language while having very different regulations and language requirements, such as idioms and nuances.
For instance, France, Canada and Belgium might all have French as their official language, but culture influences will shape the way the language is used. This will consequently impact the way that certain elements are translated, such as the labelling for medical devices and any marketing materials.
3.Terminology, glossaries and translation memories
Terminology is a critical part of translation, and a good knowledge of medical jargon is essential when translating medical documents. If you have a glossary or have previously worked with translation memory technology, you can share this with your chosen translation provider. This will help keep terminology consistent across all of your documents, while also ensuring accuracy and helping speed up the translation process.You can also use internationally recognised symbols, such as the ones listed by the International Organisation for Standardisation (ISO). That way, you can make sure that all your files are kept consistent and accurate.
4.Editable files vs. non-editable files
When preparing the documents for your translation agency, avoid sending non-editable or read only files. These types of files, usually scans, will require desktop publishing skills in order to convert them into files the translator can edit. This will result in delays, causing your project to take longer.By sending editable files we can work on straight away, you can help speed up the process and avoid any delays.
5.Editable files vs. non-editable files
When preparing the documents for your translation agency, avoid sending non-editable or read only files. These types of files, usually scans, will require desktop publishing skills in order to convert them into files the translator can edit. This will result in delays, causing your project to take longer.By sending editable files we can work on straight away, you can help speed up the process and avoid any delays.
Prepare your documents for the best translation
By following these 5 tips, you can make sure your medical device documents are ready for translation. This will give your translation provider quality documents to work with, in turn delivering the same level of quality and detail in your translation.
At Intertranslations, we have more than 25 years of experience in localisation and translation services. ISO certified for accuracy and quality, our commitment to excellence has seen us become one of the top translation agencies in the industry.
Working with us means that your project will be handled by industry experts who are native speakers of your target language. Meanwhile, our in-house desktop publishing team means we can work with any format and multimedia that you send us.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements which are signed by both our in-house and freelance teams.
Choosing the right translation agency is no easy task.
With globalisation making it easier to expand into international markets, medical device companies find themselves in more need of language services than ever before. When looking to distribute medical devices in foreign markets, all the relevant medical content will need to be professionally translated.
Rules and regulations of the EU market
Both individual countries and international markets like the European Union each have their own requirements and standards when it comes to medical device translations. The new EU Medical Device Regulation (EU MDR) in particular greatly impacts medical device manufacturers based in the EU, as well as those looking to enter the market.
This regulation sets out the standards and requirements—especially translation requirements—that medical devices need to follow in order to pass conformity assessments. Only when the documents fulfil all the necessary regulations can the medical device be sold within the EU. This also covers non-medical devices, such as cosmetics and contact lenses.
Under this new regulation, manufacturers must deliver documents translated into all 24 languages of the member states when targeting markets within the EU. As such, it is important to carefully choose the right translation supplier for your project. That way, you can make sure your translated documents fulfil all the regulations, giving you a smooth entrance into the international marketplace.
But how do you know which translation agency is right for you? Here are 4 factors you should pay close attention to when choosing your language service provider.
1.Experience
When choosing a translation company, one of the main points to consider is experience. How much translation experience do they actually have? Do they specialise in medical device translation, or at least have some experience in the field?
If your translation agency has experience in the medical industry, then they should be able to translate a range of document types in various languages. Each type of document requires a different approach, and experience is generally a good indicator that the agency will know the best course of action.
Medical device documents are highly technical and require specialist medical knowledge, so it is best to choose an agency that knows how to handle them correctly. The more experience they have, the easier it will be to work with them.
2.References and certifications
While researching agencies, it might be wise to ask any companies that catch your interest for their references and certifications.
References provide proof that the translation agency has worked with other customers, and shows how satisfied those customers were with the service they received. This is also a great way to see if they have worked for companies similar to yours or from the same sector, validating their experience.
Certifications like ISO 9001:2015 and ISO 13485:2016 show that the agency has processes in place to ensure the accuracy and quality of their translations. By choosing a translation company that is ISO certified, you will know that every step will be taken to deliver the best possible translation.
3.Compliance
Life sciences and medical device labelling depend heavily on standards and guidelines defined by both local and international regulations. As such, professional translation providers must know about the regulations, standards and systems in place within your target market.
A lack of knowledge can have severe consequences, leading to failed applications or conformity assessments. Even worse, ignorance could lead to a translation that breaks national laws.
The translation company you choose must work with translators who know all about the rules and regulations in place within your target market. Only then can they deliver translations that comply with local laws, helping you enter your new market smoothly and successfully.
4.Communication and management
Communication is key to a successful project, so pay close attention to the way translation companies interact with you. Any unclear or confusing communication might become an issue later on, so make sure you can communicate freely with your chosen agency. This will be especially important when it comes to managing your project.
Your chosen company must also have a quality management system in place. This includes the use of translation technologies like translation memories, glossaries and term bases. These help keep translations consistent, which will in turn contribute to the quality of your translation.
Looking for a translation agency?
Finding the right language service provider that suits your specific needs is not easy. However, looking out for companies that tick all four of the above boxes should help make the task a little easier.
At Intertranslations, we have been helping clients with all their communication needs for more than 25 years. ISO certified for accuracy and quality, our commitment to excellence has seen us become one of the top translation agencies in the industry.
Working with us means that your project will be handled by industry experts who are native speakers of your target language. Throughout your project, our translation and localisation specialists will be on hand to help, guiding you through our translation process step by step.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements, which are signed by both our in-house and freelance teams.
New regulations mean new standards and guidelines for global markets.
The medical device industry is subject to strict regulations, guidelines and standards, especially when entering global markets. Lately, the new European Union Medical Device Regulation (EU MDR) adopted in 2017 has had a big impact on the industry worldwide. Following a 3-year transition period, this regulation is now in full effect and should have been implemented into the national systems of all member states.
Contrary to the former European Medical Device Directive (MDD), this new regulation is mandatory for all countries that are part of the EU. As a result, the translation industry has found a need for change and adaptation. This is especially so for medical device translation, since it is essential to comply with this new legislation in order to label devices correctly.
But translating documents relating to medical devices involves a whole lot more. Here are just 4 of the many different factors that translators need to be aware of when handling your documents.
1.Regulations and updates
Translating documents related to the medical industry—and more specifically medical devices—means complying with local and international regulations. In order to sell products within the EU, medical device manufacturers need to pass conformity assessments with the notified bodies. This involves compliance, respecting the standards and guidelines established by the member states of the EU.
These rules and regulations are constantly evolving. For instance, the Medical Device Directive (MDD) required medical device content to be translated into the chosen languages of the target country, along with one other official EU language.
This has now changed in accordance with the new European Medical Device Regulation (EU MDR). Instead, manufacturers and pharmaceutical companies must now translate their documents into all 24 languages of the EU member states.
These languages are: Bulgarian, Czech, Croatian, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Irish, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish and Swedish.
This means the MDD has officially been replaced, and products that once complied with the MDD can no longer be sold within the EU. As such, all medical device documents must now comply with the EU MDR instead.
If your product is to successfully reach your target market, then your chosen language service provider must pay close attention to any changes in regulations. That way, you can avoid any delays and ensure your product has the best chances of reaching your target market.
2.New devices classified under ‘medical devices’
Alongside changes and updates in regulations, more devices are now classified as ‘medical devices’ under the new EU MDR.
Initially, medical devices only referred to equipment used within hospitals and the pharmaceutical sectors. However, under the new regulation, medical devices are now described as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.”
This means that devices which have no medical purpose now fall under this category, such as cosmetic devices or contact lenses. Medical device labelling also takes into consideration not only the device itself, but also all the materials relating to the device’s composition and its use.
3.Conformity assessments
During the translation process, the translation agency must be very careful when it comes to documents which are going to be used for conformity assessment. If mistranslated, even a single word could be reason enough to argue that the device has not conformed to EU laws and regulations.
The CE marking—which stands for “Conformité Européenne”, or the mark for European Conformity—allows manufacturers to sell their devices within EU member states. With a failed conformity assessment, the product will not receive this mark and can therefore not be legally sold within the EU.
If the medical device is to conform to European legislations, then the translation must be true and accurate to the original text. It must also be consistent across all 24 of the EU’s official languages.
4.Translation quality
With the introduction of the EU MDR 2017, standards have tightened regarding accuracy and detail for medical device labelling. Consequently, translation requirements have also become stricter.
Professional language services provided by translation companies are necessary in order to pass conformity assessments and understand changes in regulations. However, they are also important for reaching the right target audience. By accurately labelling the devices with high-quality translations, your target market will be able to use the product correctly and safely.
The requirements regarding labelling a medical device might differ from one country to another, even if they speak the same languages. For example, France and Belgium are both French-speaking countries, but have very different regulatory systems. In some countries, regulations might even differ between regions, especially in federal states like Switzerland which might have different requirements depending on the particular canton.
As such, it is important to seek professional translation services for your medical device documents. Professional translators will take your target market and its requirements into account while carrying out your translation project, delivering high-quality translations that comply with regulations.
Choose a professional for best results
When translating medical device documents, the above factors need to be considered throughout the project. Otherwise, the consequences could be serious, causing delays to market or health risks to your users.
At Intertranslations, we have been handling medical device translations for more than 25 years. Through our experience, we have become one of the top translation companies on the market. This experience has allowed us to refine our processes to ensure we deliver high-quality translations every time.
We will make sure all your documents are handled by experienced subject matter experts and who are also native speakers of your target language. Our translation specialists will then carefully guide you through our process, keeping communication clear for services you can trust.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements, which are signed by both our in-house and freelance teams.
If you would like to see our references or ISO certifications for accuracy and quality, then contact one of our translation specialists. They are on hand and happy to help with any questions you have about the services we offer.
Do you have a translation project? We can help.
Whenever there are changes or updates in industry regulations, the language industry has to adapt as well. Language service providers need to keep up to date with any of these changes in order to deliver documents that meet translation requirements. Otherwise, the translations they produce could have dire consequences for their client’s reputation, not to mention the financial and legal repercussions.
In 2017, the EU medical industry underwent a complete reform following the introduction of the new European Union Medical Device Regulation (EU MDR). With a three-year transition period, manufacturers are now legally obligated to comply with this new regulation, which features guidelines for medical device manufacturing.
However, the EU MDR also covers devices which are not intended for medical purposes, such as cosmetic devices or contact lenses. As such, any product intended for used for humans must also comply to these new guidelines. Because of this new regulation, language services now play a central role in helping manufacturers from various sectors enter EU markets.
In light of this new regulation, there are 3 points you need to consider when looking to enter the EU market with regards to translation.
1.Regulation content
This new regulation has brought about a lot of new requirements for translation service providers. The standards for medical device translations are now stricter, and translation companies must be able to deliver.
First off, the EU now requires products to have more thorough labelling. Medical device content now needs to be translated into all 24 official languages of the EU. Each word has significance, and if just one is mistranslated, this could lead to severe financial or legal consequences. As such, translation agencies need to take great care when translating medical device documents in order to ensure all 24 languages are accurate and consistent.
Translation agencies must work with native speakers of your target language who are experts in your sector. Their language proficiency will help greatly in translating documents as accurately as possible, while their expertise will ensure your translations comply with regulation updates.
2.Conformity assessment process
The new EU MDR has also brought about new standards in terms of conformity, calling for more quality control with regards to the CE marking. This is a declaration from manufacturers testifying that their product complies with EU standards.
Under this new regulation, documents must be submitted to the notified bodies for conformity assessment as part of the product’s technical documentation. This includes instructions for use, directions for use, and any other technical files. The category of medical devices also incorporates a wider range of products, covering any item to be used by humans.
As such, language services hold even greater importance for a wider range of companies looking to expand into European markets. With the EU MDR applying to more devices and requiring more documents for conformity assessment, this new regulation has greatly impacted the translation industry.
3.Terminology
Under this new regulation, even new devices that are not intended for medical purposes must comply with the same guidelines and standards. This has broadened the spectrum of devices and documents that will need translating, and consequently any specialist terminology involved.
Terminology is an essential part of translation and international trade. One mistake could lead to a failed conformity assessment, with great financial repercussions. In order to prevent this from happening, we have created industry-specific glossaries, term bases and translation memories which we work with on a daily basis. Using these tools helps us crosscheck for any discrepancies while translating.
New regulations mean new ways of translating
The new EU Medical Devices Regulation has not only impacted the medical industry, but also the translation industry. With more devices being covered by this regulation, the demand for language services has increased. Meanwhile, changes in the conformity assessment process mean a greater workload, with more documents needing to be translated into more languages.
At Intertranslations, we have been providing clients with quality translation services for more than 25 years. Drawing on this experience, our team has been able to adapt our services quickly to meet these new regulations, continuing to deliver high-quality translations.
ISO certified for quality and accuracy, working with us means you will be working with one of the top agencies in the translation industry. We adapt our services to suit each client’s individual needs, taking every step possible to ensure you receive the best results.
We do this by working with native speakers of your target language, who are also experts in your sector. From start to finish, our translation specialists are more than happy to guide you through our entire translation process.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements, which are signed by both our in-house and freelance teams.
In order to ensure that your translations comply with these strict regulations, choose your language service provider carefully. Make sure that they work with translators who are native speakers of your target languages, as well as experienced industry and subject matter experts.
Delivering high quality medical device translations requires good practices from start to finish.
Globalisation has greatly increased the need for language services within the medical device industry. More and more manufacturers find themselves in need of services from professional translation companies in order to sell their products within their target market.
The two biggest markets when it comes to medical devices are the United States and the European Union. Both of these markets have their own medical device regulations and translation requirements. As such, manufacturers and translation agencies alike need to pay close attention to these regulations, adopting practices that will produce high-quality translations accepted by global markets.
This is especially important when looking to translate product labels, which allow manufacturers to sell their products in a particular country. For instance, the CE marking allows products to be sold within the EU. This mark can only be obtained through strict assessment, and depends entirely on the translation of all the documents related to the device.
Our team at Intertranslations has put together a list of the 5 best practices to follow when it comes to translating medical device documents.
1.Keep it consistent, clear and concise
In order to ensure you get the best quality translation, the original documents must be clear and concise. This will help make the translation process go faster, with less time being spent on back-and-forth exchanges trying to clarify any unclear areas.
If the source texts are clear and concise, this will be reflected in the final translated documents. It will also help your chosen translation provider keep your translation consistent across all of your files.
2.Certifications
Choosing a provider to carry out your translation is a task that should not be taken lightly. It is important to make sure your agency has certifications, something that we cover in more detail here. You should especially keep an eye out for any International Organisation for Standardisation (ISO) certifications.
ISO certifications, especially ISO 9001:2015 and ISO 13485:2016, show that the agency has accuracy and quality management systems in place. Any company possessing these ISO certifications will be able to guarantee the accuracy and quality of your translations.
3.Terminology and symbols
Terminology and symbols are impossible to avoid when it comes to medical device translation. In order to ensure consistency, translation agencies should ideally work with translation memory technology, glossaries and term bases. These tools will allow them to cross check the translation and verify that there are no discrepancies in terminology.
Another good practice is the use of internationally recognised symbols and icons. By using symbols recognised by medical professionals and users, you can make sure that no concept or meaning gets lost in translation.
4.Experience and expertise
Choosing an experienced translation company is the safest way to ensure your translation project will be handled by an agency that understands your industry. The medical industry requires an in-depth knowledge of specific terms and processes, both in the source and target language. As such, the translation must be carried out by professional translators who are both subject matter experts and native speakers of the target language.
With regards to accuracy and quality, your project will benefit greatly from choosing a company with experience and expertise. This is also a regulation requirement when it comes to medical device labelling processes and life sciences in general.
5.
Multimedia
Medical device products often have documents in various multimedia formats, a practice that has become more common over these last few years. Indeed, videos, diagrams, graphics and even animations are great ways to show how to use a product.
As such, your translation supplier needs to be able to work with different file formats, as well as different types of media. Some media like animations might also need localisation services rather than translation, so your supplier also needs the ability to offer the right services.
Follow these practices for a quality translation
In order to make sure the translations you receive meet all the necessary requirements, follow these 5 practices. This will help you prepare your documents ready for translation, while also helping you choose the right agency for the project. By ticking all these boxes, you can make sure you will receive a quality translation, giving you time and money well spent.
At Intertranslations, we have more than 25 years of experience in translation and localisation. ISO certified for accuracy and quality, we have adopted strict practices to deliver quality services every time. This commitment to excellence has seen us become one of the top translation providers in the industry.
By working with us, you can be sure that your documents will be handled by subject matter experts and native speakers of your target language. Meanwhile, our in-house multilingual desktop publishing team are ready to work on any file format or type of media for a comprehensive translation service.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements, which are signed by both our in-house and freelance teams.
Globalisation has brought about big changes within medical device industries, offering businesses a greater global reach than ever before. Trading with foreign companies or customers is now a daily occurrence.
In order to reach this global market, medical device companies rely heavily on translation services and have three options available to them:
• Hire freelance translators
• Hire in-house translators or staff members who speak the target language
• Work with a professional translation agency
However, these three options each have their differences, and this will be mirrored in the quality of the translations you receive.
So, how do you know which is the best solution for your company? When it comes to medical device translation, there are 5 key factors that you should take into consideration when choosing your translation provider.
1.Regulations
The medical device industry is subject to very strict rules and regulations. In order to provide accurate, high-quality translations, the provider must know all about the systems in place in your target market. This includes local legislation, guidelines and standards, as well as international legislations.
These regulations are also subject to changes and updates. In 2017, it was voted that the new EU Medical Device Regulation (EU MDR) should replace the EU Medical Device Directive (EU MDD). The MDD is no longer legally valid for trade within EU countries, and the content differs greatly from the new EU MDR. If a translator is unaware of such changes, then this could directly impact your chances of successfully entering a new market.
Moreover, some countries have different local requirements, standards or even laws depending on the region. This is common in federal countries like India, Germany, Switzerland and Russia where rules vary depending on the federated states, Länder, cantons, or federal subjects.
Without background knowledge about the applicable regulations of your target market, the translated texts might not comply with regional, national or international laws. As such, your translations need to be carried out by subject matter experts who have experience with medical device regulations. That way, you can be sure they have the ability to handle your translation accurately and correctly.
2.Experience
When choosing your translation service provider, experience is another important factor. Years of experience in the industry indicates a certain savoir-faire regarding industry criteria and translation requirements. Extensive experience also implies that the provider regularly handles documents such as information for use and hardware or software manuals.
Experience also indicates that they are professionals who understand the specific jargon that comes with different types of files and products. More specifically, an experienced provider will know how and when to use or translate brand names and generic names. This is particularly important since the pharmaceutical industry handles both brand names and generic names of medications. For life sciences and medicine, this is also the case with names of diseases.2.
3.Certifications
Look out for certifications when researching your translation provider, especially International Organisation for Standardisation (ISO) certifications. These will guarantee that your translation provider has systems in place for quality control and risk management.
The two you should keep an eye out for are ISO 9001:2015 and ISO 13485:2016, which are related to accuracy and quality. Another you should try to look out for is ISO 17001:2015, which relates to translation management systems and data security.
These three certifications guarantee quality, accuracy and data protection. In contrast, hiring a freelance translator, in-house translator, or staff member to translate your medical device documents will not guarantee accuracy or quality.
Translation companies are required to have these certifications, demonstrating their commitment to the profession. If you need a certified translation, then it would be best to consider working with a professional translation agency that specialises in your sector.
4.Localisation
Translating documents related to medical devices is a delicate affair, since the translation will influence the product’s success within the target market. When it comes to marketing, a simple translation in the target language will not suffice. In order to create an effective marketing campaign, the translation process needs to dig deeper, also taking into account cultural aspects and nuances.
Adapting your text for marketing purposes is called localisation. While translation crosses linguistic barriers, localisation crosses cultural ones. These two services are closely connected and often overlap. As such, your medical device documents need to be translated by subject matter experts who have also mastered the target language and all its nuances. That is why it is always best to work with translators who are native speakers of your target language.
5.Tools
Translation companies have a variety of professional translation tools at their disposal. From computer-assisted translation (CAT) tools to translation memory technology and glossaries, it is important to know how your chosen provider will carry out your translation.
Working with these professional tools is a great way to ensure consistency across different documents. By creating glossaries and term bases, translators can crosscheck against previously translated content, making sure there are no discrepancies between the files.
This is extremely important, especially for medical device manufacturers who need deliver their translated documents to a notified body in order to pass conformity assessments. Mistranslations, poor quality or discrepancies could be reason enough for your product to fail a conformity assessment.
The European Conformity mark, or CE mark, allows manufacturers to sell their products within countries that are part of the EU. The new EU MDR now imposes stricter standards to get this mark. In order to comply with these standards, documents must be translated into all 24 official languages of the member states.
By using professional translation tools, your translation provider can ensure consistency across all languages and documents, giving you the best chance of success.
Looking for a professional translation agency?
When it comes to translating your medical device documents, keep in mind these 5 factors while choosing your translation provider.
At Intertranslations, we have been handling medical device translations for more than 25 years. ISO certified for accuracy and quality, we have become one of the top translation providers around thanks to our extensive experience.
Working with us guarantees that your documents will be translated by native speakers of your target language, who are also industry experts. Meanwhile, our project managers are on hand to guide you through the entire translation process, so you can feel confident in the services you receive.
We also know that security is essential for protecting your data and information. Our company is fully GDPR compliant and offer non-disclosure agreements, which are signed by both our in-house and freelance teams.
Working with Intertranslations means that:
• Your documents will be handled by native speakers who are industry experts.
• Our translation specialists and our project managers will guide you through our translation process, building a lasting relationship based on trust.
• Your privacy is guaranteed through our General Data Protection Regulation (GDPR) compliance and non-disclosure agreements.
• You will be working with a company that has references and is ISO certified for accuracy and quality.