Industry Specialization: Device Manufacturers

Translation for medical and surgical device manufacturers is increasingly perceived by regulators and Notified Bodies as a key outsourcing activity. Issues related to outsourcing and supplier control are at the core of the ISO 13485 standard. This is one of the primary reasons why more and more device companies are outsourcing their medical translations to ISO 13485-certified translation companies. This is also the reason why in 2008, Excel Translations has made the necessary investment to become ISO 13485:2003-certified, effectively aligning its quality processes with its clients' in the medical device, diagnostic, hospital supply, and dental supply industries. Follow this link to understand why this certification is important to medical device manufacturers. BSI Management Systems America, Inc., a leading global provider of management systems assessment and certification solutions, awarded Excel Translations the ISO 13485 certification for its translation services in 2008.

Device companies should also be aware of the requirements of Directive 2007/47/EC and learn about instances when software is now considered a medical device, what has changed for European market clearance, why software needs to be translated before the March 2010 deadline, what they need to do to be compliant before March 2010, and how we can help schedule their transition to full compliance.

For the past 10 years, Excel Translations has been helping device companies such as Abbott Vascular (formerly Guidant), Medrad, or Volcano with the translation, typesetting, and in-country review of:

• IFUs and inserts
• Installation Manuals
• Marketing Communication Collaterals
• Operating Manuals
• Packaging and Labeling
• PowerPoint Presentations
• Software Application Interface
• User Manuals
• Web-based Content

Our customers in the medical device industry require one solution provider that can meet all their foreign-language needs, both current and future, typically in a number of languages simultaneously. Excel Translations specializes in the simultaneous translation and delivery of projects in as many as 30 languages.

In addition we offer full DTP and typesetting capability in a variety of software and hardware platforms for both print and single-source publishing (web) formats. We have the ability to generate virtually every major alphabet, including non-Romance languages, and offer state-of-the-art design, layout, and image-setting solutions. We handle all industry-standard typesetting programs for both Macintosh and PC and specialize in simultaneous product launches in multiple languages. We can also easily integrate with your Content Management System to realize improved time and cost efficiencies.

We routinely work with the following applications and formats.

Latest Versions of Print DTP and Graphics Applications (both Mac & PC):

• FrameMaker
• InDesign
• Illustrator
• QuarkXPress
• PageMaker
• Interleaf
• QuickSilver
• Photoshop
• CorelDraw