5 Best Practices for Medical Device Translation

Last Updated May 26, 2021

Medical device translation is one of the most complex and demanding types of translation. And doing it right saves lives.

The medical device industry is among the largest industries in healthcare. It is constantly driven by new technologies and innovations that have contributed to the development of quality high tech medical devices, such as surgical robots and high-tech nanotechnology applications.

The global medical devices market size was valued at US$ 447.63 Billion in 2019 and is expected to be worth around US$ 671.49 billion by 2027.

As the medical device industry grows, so too does the global need for professional medical device translation services.

Let’s take a deeper look at the importance of medical device translation, why you need it, and how we can help.

Why Medical Device Translation Requires the Utmost Care

The future of the medical device industry is very bright, but one problem that some stakeholders are facing is the increasing regulatory requirements.

Additionally, the regulations keep changing, making it harder for medical device companies to rapidly respond to opportunities. That includes ensuring that products get to the market quickly.

Increased regulatory scrutiny has made it necessary for medical device companies and manufactures to turn to technology an effort to identify methodologies that are cost-effective, assure safety, increase the effectiveness of devices, reduce non-compliance risks, and increase the speed to market.

It’s here that effective medical translation begins to come into play.

The process of successfully launching a product or device in a foreign market can be daunting. This is due to the administrative and linguistic problems that diverse and stringent regulatory requirements persistently raise.

Due to the complex nature of the industry, many medical devices companies are at risk of facing compliance issues when expanding to foreign markets around the world. Here are a few examples:

  • When offering products in Canada, businesses must closely adhere to various French translation guidelines.
  • Mexico requires the translation into Spanish of the label with information as required by Official Mexican Norms and the Instructions for the device’s use or operation manual.
  • While Brazil’s healthcare translation requirements are dictated by Anvisa.
  • Malaysia’s medical device regulations are similar to the classification scheme used in the European Medical Device Directive (MDD) 93/42/EEC.

The import and distribution of medical devices in different countries are subject to strict approval processes, and compliance measures. Regulatory bodies in each country set them. In many cases, one requirement is medical document translation in the official language of the country.

Some of the materials that regulatory bodies normally require to translate include:

  • packaging and labels
  • marketing materials
  • instructions for use
  • software and user interface

In general, you need to translate all documents such as clinical trials, administrative documents, and quality management system certificates that regulators will use to assess a device and approve whether it can be imported and distributed to the target market.

These requirements make medical translation integral in the medical device approval process.

How to Prepare for Medical Device Translation

There are two key things you need to do before you begin the medical device translation process.

First, identify your audience.

The target audience for your products and services may vary from medical staff to maintenance teams to patients. All of them differ in background and educational levels, so the written document will vary in level of complexity and use of technical terms or scientific language.

If you are targeting patients, always keep simplicity in mind. Keep the text at an 8th grade level. Expressions used among medical professionals cannot be used as-is in a brochure or form that is intended for patients.

This simplified language will also make the translation process easier.

Second, establish a process to reuse content.

By avoiding unnecessary changes in the source text and applying approved glossaries and style guides, you can benefit from long-term benefits such as quality assurance, consistency, and savings.

Your translation and localization vendor should use translation memories and translation management systems to handle your updates and can recommend methods and tools to manage your glossaries and style guides.

Medical Device Translation & Localization Best Practices

You should always expect absolute precision when it comes to localizing and translating your company’s medical device documentation. Don’t approach translated device documents as an afterthought, especially when trying to enter a foreign market.

Here are five core best practices to follow during the translation process. As a rule, they can help guarantee quality medical device documentation translations. This is regardless of the local regulations and languages your translation service must contend with.

1. Offer Clear and Concise Instructions

You may have experience navigating the American Food and Drug Administration’s (FDA) application process. When it comes to obtaining device approvals overseas, be prepared for extra regulatory hurdles.

A good medical device document translation services will help you overcome them.

Creating clear, concise, and consistent medical device instructions is one of the most vital components in streamlining this process. It is also important to keep costs as low as possible.

Look at the European Union (EU) as a prime example, with its big list of language requirements. You can quickly see how adhering to simple, clear, and concise translations can help companies avoid complications.

In order to get the coveted CE marking and logo that signifies “products sold in the EEA [European Economic Area] have been assessed to meet high safety, health, and environmental protection requirements,” device manufactures usually need to provide translations of their device’s instructions for use into the EU’s 24 official languages.

2. Make Use of Reliable Medical Writing Techniques

When dealing with anything medical, always translate clearly and concisely.

This means steering clear of acronyms, which vary from language to language, and abbreviations, which also vary widely. Avoid idioms and unnecessarily complicated terminology as they often don’t translate well across languages.

When a simpler linguistic choice is available that gets the point across, go with that. Also, avoid slang, no matter how trendy certain colloquial terms might be now.

Using simple language will help ensure that the translated documents will comply with the EU’s Medical Device Directive. It will also earn you the CE mark.

3. Work with Human Translators with Medical Expertise

While machine translation has its place, when it comes time to translate healthcare documentation, medical device companies can’t afford mistakes. Translation snafus can potentially be devastating to a firm’s image and financial health.

This is why you should always work with an ISO certified medical translation company. One that relies on the skills provided by human translators with medical expertise.

Specialized medical translators serve as protection against errors coming from translators not trained in the medical field. They should ideally be in-country and with extensive medical experience. They should also be supported by professional project managers in a translation company’s main office.

You should also work with translation specialists with expertise related to your specific medical device, to further guarantee error-free, easy-to-understand translated text.

4. Make Healthcare Labeling As Clear as Possible

As we’ve already touched on, you’ve got to avoid industry lingo and jargon on your labels.

Also, write (translate) clearly and concisely, making device labels a cinch to read and understand at first glance in any language.

When allowed, try to use well-known symbols that transcend languages and borders, as outlined by ISO 15223-1:2016. For example, use the international symbols for “caution,” “manufacturer,” “keep dry,” “fragile, handle with care,” and “biological risk.”

By including symbols whenever possible, the device labeling becomes more attention-grabbing (what any good label should do) while simultaneously decreasing the danger of adding improperly translated text. Note that symbols usually take up less room than text.

Concise, jargon-free translated text, symbols, and even easy-to-understand images and graphics can help you gain access to foreign markets. They do that by making your medical device labeling ridiculously simple to comprehend. They will also reduce translation and quality assurance costs.

5. Stay Up to Date with International Medical Device Documentation Requirements

We can’t stress enough how important it is to stay up to date with medical device documentation translation requirements for the regions you’re working in.

The medical device industry is massive. National regulators are constantly altering and updating local regulations to deal with new technologies, emerging device sectors, and even device trends that might be hitting the local news.

It’s a lot to keep track of, which is why you should select an experienced medical translation company, one that works with knowledgeable medical translators who can handle device regulations in different countries.

Find the Ideal Medical Device Translation Company

Not every company is equipped to handle your medical translation needs.

Experienced staff in regulatory requirements and translators in medical terminology is essential.

Couple that with ISO Certification, exemplary quality and service levels and an impressive list of clients in the field and you have the potential of a long-term successful partner.

Contact Summa Linguae today to get started.

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