Why Medical Device Translation is So Important

The world is made up of different races and ethnic backgrounds. We have unique upbringings, distinct cultural habits, and practice different religions. But regardless of where we come from or who we pray to, we are affected by the same health issues.

As the world struggles with the same diseases and illnesses, it’s imperative that all nations share their discoveries in medicine. An innovative treatment developed in another country could be as beneficial, and save the life of a patient living on an entirely different continent.

Since healthcare is a global issue, nations recognize how sharing medical knowledge and developments can save more people worldwide. However, it’s not enough to merely exchange literature or equipment.

It’s essential that the doctor or medical device user understands the documentation or instructions for use. However, not everyone speaks the same language. People shouldn’t be denied the benefits of a life-saving treatment just because their local health practitioners couldn’t understand how to administer the medicine or operate a medical device.

In the healthcare industry, medical translation plays an essential role in helping healthcare professionals effectively communicate with their patients who speak a different language. It’s vital that patients fully understand their diagnosis and treatment options.

For this reason, medical translation plays an integral role in healthcare as it translates medical documents so that patients who speak another language receive the necessary care and prescribed treatment. It also involves the translation of any clinical, technical, or regulatory literature associated with pharmaceutical products and medical devices.

Medical Device Translation

Medical devices are any tool or equipment used in the industry – from something as simple as a thermometer to an implantable pacemaker to an infant incubator. All these devices play a role in saving lives; therefore, the proper use of them is crucial.

Because all patients and healthcare practitioners should have access to medical devices that are accurately expressed in the country’s native language, medical devices must comply with defined rules and regulations before they can reach the market. In fact, some countries enforce their own medical device translation requirements. For example, the European Union states that all medical devices in the market must have documentation in the official language of each nation; that’s 24 different languages across the 28 member states of the EU.

Therefore, if you are a manufacturer of a medical device, your product must comply with standard operating procedures before you can bring it to market. In the US, these national and regional directives are set forth by the FDA. Devices are classified into three classes: Class I, II, and III.

Depending on your product, the following medical device documents should be translated into the relevant languages:

  • Product description
  • Packaging labels and inserts
  • Regulatory compliance
  • Product Catalogs
  • Instructions for Use
  • Software application
  • Informed consent forms
  • Patents

Translations should be executed only by the most trained professionals. Inaccurate translations could lead to costly medical errors or worse. For this reason, the human translator should have a thorough understanding of medical terms as well as have localization skills.

It could be a matter of life and death if a medical device doesn’t come with instructions in a language the user can understand. Medical device translation is more than just ensuring the product is market-ready; it’s about protecting health and safety.

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