MEDICAL DEVICE TRANSLATIONS AND LOCALIZATION
As U.S. based and internationally based and internationally medical device manufacturers expand their reach to numerous countries around the world, they recognize the importance of translating and adapting content for their target markets. This is done for many reasons and for many departments which include compliance & regulatory, marketing, distribution, legal, and human resources to name some. Currently, over a quarter of medical devices made in the US are exported to other countries.
ISO 13485 & 9001 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. We have an outstanding translation system which includes, experienced projects managers, skilled translators, and editors and as well as superior editing and proofing teams who provide multiple rounds of proofreading and editing by native speakers of the target language.
Does your LSP have this certification?
We are equipped to tackle translation projects in over 200 languages. Click here for a full list.
TYPES OF PROJECTS WE TRANSLATE
Every day we translate a wide variety of documents, and subject matters for our medical device manufacturing clients. These documents vary from project to project and by language combinations. Samples of some of the projects are listed below.
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. Operating, Maintenance and Installation Manuals, Development Safety Update Reports (DSURs), Regulatory Compliance Documents for European Union and Asian countries, Software Application Interfaces and Documentation, Package Inserts and Labels, Patents for Medical and Surgical Devices, Manufacturing Process Descriptions, Suspected Unexpected Serious Adverse Reactions (SUSARs)
We handle a wide variety of languages. Some of the more common day to day languages are Spanish, Portuguese (Brazilian & EU) , French, ( EU & Canadian) German, Italian, Ukrainian, Russian, Armenian, Chinese, (Simplified & Traditional) Korean, Japanese, Arabic, Turkish, and Hebrew. Since we offer 200+ languages, in total, there are also many of other languages we complete. Languages like Khmer, Hmong, Swahili, Afrikaans, Thai, Swedish, Norwegian, Dutch, Finnish, and Norwegian are some examples.
TRANSLATIONS HAVE A LARGE IMPACT ON REGULATORY DIRECTIVES
Translation services have a large impact in meeting the regulatory directives in the U.S. and abroad for different nations. In general, medical device documentation and labeling must be available in the official dialects of every country.
NEW EU REGULATIONS:
The EU has enforced 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 and are noted specialists in this area. We have completed numerous projects, throughout the years, 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 CERTIFICATION||OUR VAST INDUSTRY KNOWLEDGE||OUR DESIGN ABILITIES||OUR USE OF TECHNOLOGY|
|Quality is at the center of everything we do, and it shows! We deliver high quality, consistent translations at great prices.||This Medical Device industry-specific certification is proof of our dedication to the medical device field. It is also indicative of the outstanding work we do.||AML-Global has been working effectively with medical device manufacturers since 1996.||Expert linguists provide desktop publishing services on all major publishing software.||By the frequent use of Preferential Glossaries, and the use of Translation Memory we’re able to cut costs and save money and time.|
SECURITY COMPLIANCE AND DATA PROTECTION
Security Compliance is a very important factor when working with medical device manufacturers. To that extent, we take extraordinary measures to make sure your important information is safeguarded. Outlined below are some key features of our systems.
- Encrypted data, end to end, through our file sharing protocol.
- Audited and comprehensive risk analysis.
- World class secured document management system.
- Multiple privacy & security safeguards.
- Updated firewalls and antivirus software.
- Multiple server redundancy.
- Offsite Cloud data backup.
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.