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by | Jun 3, 2023

What are the requirements for medical device translation?

Whether you’re entering a new market with a medical device, or simply pushing an update for a product’s user interface (UI), both efforts require accurate and quick translation. To win the approval of regulatory bodies and protect the safety of patients, your organization needs consistent, precise translations for every UI, user guide, or marketing content deliverable. Therefore, there’s never a bad time to understand your requirements, revisit your translation workflow, and make improvements.

Which documents require translation?

The regulations are still evolving around the exact requirements for medical device documentation. Producing equipment for export into markets around the world means staying up-to-date with relevant developments in each region, even before translating that content.

For instance, the 2021 update to the European Union Medical Device Regulation (EU MDR) has laid out the latest documentation rules for equipment released into the EU market. The update included many of the rules for devices paired with medicines.

The EU MDR is a good stand-in for the kinds of regulations medical device manufacturers have to comply with in other jurisdictions as well. It outlines the ways in which companies must make comprehensive safety documentation about their medical products clearly and publicly available. For instance, the EU recommends companies follow ISO standards to make sure their documentation is widely accepted by international authorities.

The kind of safety performance documentation required by international bodies is only the beginning of your medical device manufacturing obligations. This adds complexity to medical device translation efforts. On top of these publicly accessible disclosures, you have to make sure you’re providing localized versions of:

  • Device UI: Medical equipment that contains a built-in interface must be usable in a target market’s language with prompts, terminology, and more localized for easy comprehensibility.
  • Product instructions: Manuals that go into depth about how to use a device must reflect the latest updates and be in sync with the terminology used in the UI.
  • Packaging inserts: The printed materials that accompany a medical device should be comprehensive and accurate within the space provided.
  • Marketing materials: Stylistic content comes with a different approach to writing than a device’s manual and UI, but can’t contradict those more technical documents.

The key ingredient across these many documentation types is consistency. While every content type comes with its own style and requirements, they can’t contradict one another, either in the information presented or the terms and acronyms used.

The process of medical device localization presents a specific challenge to translators: They must ensure their work does not introduce inconsistencies or unclear terminology that could put users at risk or endanger the product’s compliance status in any territory.

What are the medical device translation workflow requirements?

In the high-pressure field of medical device translation, there are significant factors that add to the complexity facing translation services teams. Having a strategic, repeatable workflow is essential because these are issues that require constant attention.

These include:

  • Compliance Across Countries: The number of languages associated with any medical device release increases the degree of difficulty. As part of the EU MDR rules , it’s noted that member states within the Union choose the required official language for medical documentation associated with releasing devices in those countries. Within the EU alone, that can amount to dozens of languages.

    The wider the range of markets your organization targets, the greater the number of languages you’ll have to work within. It’s essential to create a reliable, repeatable translation and quality assurance process for each target language, using tools such as custom bilingual glossaries to ensure consistency and efficiency over time. Without these set practices, the amount of work associated with each update can sprawl out of control.

  • Demanding Timelines: Medical device translators must not only deliver a scrupulously accurate translation for each target language, they must work quickly. The timeline for localization of a medical device UI update is often compressed. To ensure all documentation conforms to the new UI, translation on the device itself has to be completed before teams can work with supporting materials.

    This requirement creates a situation where, as a medical device producer, you may have just a few weeks to translate multiple critical documents in numerous languages. Therefore, having a repeatable, parallel, medical translation workflow for each target language can provide you with the necessary level of translation quality and compliance.

What is the ideal approach to compliance?

Building the necessary translation capabilities within your own organization can represent a large, complex, and costly undertaking. But your company can’t afford to fall short in accuracy or speed. The simplest resolution is to work with a highly qualified medical device translation service.

A translation provider with access to trained subject matter experts can deliver a level of repeatable, fast, and accurate translation to meet compliance standards across regions. This usually requires professional translators with a knowledge of medical products as well as the stylistic needs of a chosen content type in each target language.

Working with the same highly qualified translation service for each product release and update can pay repeating dividends for a medical device manufacturer, as learning curves are shortened and your organization can reuse materials such as custom bilingual glossaries. A collaborative workflow, with translators and internal medical device experts all signing off on translations, can deliver results that meet industry standards, year after year.

Linguistic Systems can meet this need for high quality medical device translation, whatever your scale or specific requirements. With a network of over 7,500 expert translators and four regularly renewed ISO certifications that attest to quality methods, Linguistic Systems can become a long-term partner to meet your most challenging medical translation requirements. Contact us to get started.

EDITOR’S NOTE: Linguistic Systems uses a combination of advanced proprietary technology and 7,500 skilled, certified translators to deliver high-quality translations in 120+ languages. With 55+ years and billions of words of experience serving 25,000 clients, including many Fortune 100, AmLaw100, and top medical and life sciences firms, you can trust us with your foreign language translations.