Medical Device Translation

Enabling Localization with Expert Translation and Content Development

As medical device manufacturers seek to expand their share in global markets, their compliance challenges are growing exponentially. Regulatory agencies around the world — including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and Japan's Ministry of Health, Labor and Welfare (MHLW) — are continually expanding language requirements for device documentation. As devices become more sophisticated, documentation is expanding so quickly it is increasingly difficult to fit instructions in all the required languages in the product's sterile packaging.

Manufacturers of electronic medical devices face the added challenge of ensuring their product's computerized components, embedded software, and user interfaces are compatible with existing regional infrastructures and user preferences. In addition, they must meet industry standards, such as GMP, ensuring traceability and accountability in production processes and systems.

With lives on the line, ensuring quality and accuracy is crucial. But device companies must also accelerate their time-to-market to remain competitive. Poor translations, however, lead to product recalls that are often devastating in the hyper-competitive medical device market.

Having an experienced partner with proven medical product expertise, integrated development and language translation capabilities, and global scale can make all the difference. Lionbridge is helping the world's leading medical device companies achieve their market objectives with:

• Translation and content development services for the full range of printed and electronic product documentation — from labels to instructions and package inserts — with consistent and defined quality and accuracy processes to ensure compliance and to minimize risk
• Application development and testing services, including integration of back-end and customer facing systems and data migration/conversion, to help ensure compliance with production systems' validation requirements, including IQOQPQ
• Product localization services to ensure device hardware and embedded software are fully compatible with existing infrastructures for each target market, and to ensure products provide a consistent experience across all languages
• Training localization services for product users in their native language to ensure appropriate product use, and for sales representatives to accelerate training and enhance sales success

Lionbridge provides the scalability to launch products in multiple global markets simultaneously, without increasing the burden on in-house staff. And we reduce cost and complexity by providing a single, flexible source for a wide range of content and technology localization services, for markets around the world.