What You Should Know About Localization Of Medical Device Products

In order for you to start and continue an international business in the Medical Devices industry, you will need a proper localization service. It will help you reach an international audience and spread your product globally across the world market.

Medical Device Localization is…

Medical device localization is a process of adapting content related to medical devices for the target audience. The content can be:

  1. Technical documentation (manuals, instructions-for-use, etc.)
  2. Regulatory documentation (ISOs, licenses, etc)
  3. Software (both apps and websites)
  4. Marketing information (leaflets, ads, promotional campaigns, etc.

Overall, medical device localization will help your patients and doctors understand how to use this or that medical device without difficulties.

Medical Device Localization Stages

Now, when we define what is medical device localization is, let’s get to steps or localization stages

Initial Planning

During initial planning we should decide the following things:

  1. Language pairs
  2. The target audience: professionals or common users?
  3. Field of expertise: pharmaceutical, medical, etc.
  4. If it is an app, do you need optimization in the future?
  5. Is there any additional documentation you need to localize?
  6. Do you localize your product to other international markets?
  7. Budget

Receipt Of Source And Supporting Materials

Then, we will gather all source and supporting materials and make sure everything is in order. After this we will study those materials carefully to prepare for the next step.

Translation Process Itself

The translators and proofreaders work on the texts, ensure that the text matches the meanings of the source text. QA is responsible for identifying mistakes and errors if any. Editors make editing steps to make the text sound authentic and understandable to the target audience. Finally, DTP Specialist checks documents for formatting errors (alignment, font, color, etc.)


It is an important stage in the localization process to make sure the translated materials are free of errors and in the case of app or website: the right text is displayed on the screen, there are no breaking lines and no missing text as well as the app and website work in a correct way.

Why Do You Need To Localize Your Medical Device Product?

As you can see, medical devices do not fit in regular goods and services, as it has more complicated and comprehensive processes and stages: from production to marketing. And it doesn’t mean you should not localize medical devices at all. On the contrary, it is necessary to do it.

In the context of the healthcare industry, medical device localization is done by strictly following the country’s regulations (i.e. target audience’s regulations) and complying with QA standards. Also, it involved more and more translations, proofreadings, and quality assurance, so it would ideally comply with these regulations and standards.

Medical device localization should not be discarded, because without this process the use of the product can cause some serious and even fatal consequences.

Regulations And Certifications

We will cover international certifications and regulations that pertain to every medical device localization.

ISO Certifications

ISO certifications help translation agencies implement quality standards in the linguistic process so that the translated text reflects authenticity and accuracy. Common ISO Certifications are ISO 9001 (Quality Management), ISO 9001 (Translation Services), ISO 10993 (Biological Evaluation Of Medical Devices), ISO 13485 (Medical Devices)

USA Regulations

In the USA Food and Drug Administration is responsible for regulating the manufacture of medical devices. Also, the FDA has a mandatory Medical Device Classification (Class 1-3). Class 1 is a low-risk medical device, for example, bandages or surgical gloves. Class 2 is a medium-risk medical device, for example, blood pressure cuffs or sutures. Class 3 is a high-risk medical device, for example, a pacemaker or vascular graft.

EU Regulations

The document that is used for the regulation of medical devices in European countries is MDR (Medical Device Regulation). MDR regulates the manufacture of medical devices with the following documents:

  1. Directive 90/385/EEC on active implantable medical devices
  2. Directive 93/42/EEC on medical devices
  3. Directive 98/79/EC on in vitro diagnostic medical devices (IVDs)

According to the new regulations, medical device documentation must be translated into the official language of each EU member where you will sell your product. It means that your documents need to be translated into up to 24 languages.

How Can You Properly Localize Your Medical Device Product?

With the help of the Lingrowth Team, it will be possible. We have both in-house and outsourced linguists who hold all the necessary university degrees and Lingrowth has a huge experience in medical device localization. Our specialists-linguists, responsible Project Management, and QA Management will provide you with the best medical device localization experience!

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