MEDICAL DEVICE TRANSLATIONS AND LOCALIZATION

As U.S. based medical device manufacturers expand their reach to other countries around the world, they recognize the importance of translating and adapting content for their target markets.This is done for legal, compliance & regulatory reasons as well as for practical considerations of having companies and consumers better understand the products they are purchasing.Currently,over a quarter of medical devices made in the US are exported to other countries.

ISO 13485 CERTIFIED

To capitalize on this rising demand, American Language Services (AML-Global) opened its medical device division in 1996 and obtained its ISO 13485 Certification, in addition to its ISO 9001 Certification. ISO 13485, is a fundamental standard for companies providing medical device translations. Does your LSP have this certification?

We are equipped to tackle translation projects in over 200 languages. Click here for a full list.

TRANSLATIONS HAVE A LARGE IMPACT ON REGULATORY DIRECTIVES

Translation services have a large impact in meeting the regulatory directives in the U.S. and different nations. In general, medical device documentation and labeling must be available in the official dialects of every country. Materials that require translation include the medical device labels, Instructions for Use (IFU), instructional manuals (IM), packaging, user interface (UI), marketing materials and other technical information.

NEW EU REGULATIONS:

The EU is about to enforce its new regulations in the beginning of 2020. Is your company up on the new standards?  Are you ready to comply? To assist you in this complicated and important area, please click on: NEW EU REGULATIONS for more information.

AML-GLOBAL’S EXPERTISE IN MEDICAL DEVICE TRANSLATION

AML-Global has many years of medical devices translation expertise, is ISO 13485 certified.  We have completed numerous projects for many of the world’s leading medical device companies.

5 REASONS TO CHOOSE AML-GLOBAL FOR YOUR MEDICAL DEVICE LOCALIZATION

OUR HIGH-QUALITY WORK
OUR ISO 13485 CERTIFICATIONOUR OUR INDUSTRY KNOWLEDGEOUR DESIGN ABILITIEOUR PRICE
Quality is at the center of everything we do and it shows!
This Medical Device industry-specific certification is proof of our dedication to the medical device field.AML-Global has been working with medical device manufacturers since 1996.
Expert linguists provides desktop publishing services on all major publishing software.By the frequent use of Preferential Glossaries, & the use of Translation Memory we’re able to cut costs & save money and time.

Some of Our Happy Clients

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READY TO GET STARTED?

We’re always here for you. Contact us by email at Translation@alsglobal.net or call us at 1-800-951-5020 for a prompt quote.    

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