ForeignExchange Translations saves lives.

Our company vision comes alive every day as we strive to provide our drug and device clients with:

• Zero defects
• Significant time and and cost reductions
• Access to the very best medical translation professionals

“ForeignExchange has demonstrated to us that they have the experience, the people and the processes to support our extensive translation needs.”

We are the leading provider of medical translation services to:

• Medical Device Manufacturers
• Pharmaceutical Firms
• Biotech Companies
• In-Vitro Diagnostics Manufacturers
• Contract Research Organizations (CROs)

Specialized translators
At ForeignExchange, you won't find legal translators working on clinical trial reports. Instead, all of ForeignExchange's medical translators are vetted through our Compliance Translation Certified™.

Leading pharmaceutical companies are supported by ForeignExchange Translations

This demanding certification, developed and administered by ForeignExchange, ensures that medical translators:

• pass a rigorous screening and testing process
• have extensive experience translating life-science texts
• receive continuous performance feedback

Compliance Translation Certified linguists are just one aspect of our Multilingual Compliance Process. This ISO 9001:2000-certified process provides a roadmap for delivering multilingual products and documents on time and on budget. It combines expert linguists, best-of-breed technology and measurable translation quality in a robust and scalable process.

ForeignExchange takes confidentiality and security issues very seriously. Project-management personnel do not disclose information about specific project work to other project managers working for other clients. Approved terminology is separate for each client.

Clear internal guidelines guarantee that client-proprietary information is kept confidential. Those involved in projects are sensitized to the competitive nature of such information and are trained to act accordingly. All ForeignExchange employees and translators have signed our corporate nondisclosure agreements.

ForeignExchange translates millions of words annually for life-sciences projects that have included up to 24 languages simultaneously. Along the way, we develop innovations that help clients do their jobs more efficiently, ensuring a shorter time to market.

From Medical Alley to Silicon Valley—ForeignExchange is the leading translation vendor to drug and device companies

For example, while working with an industry-leading medical device manufacturer, ForeignExchange developed a translation system that cut the time to market in half! We pride ourselves on acting proactively to save clients money, resources and more importantly, time.

Services
Clients rely on ForeignExchange for a wide variety of medical translation and localization solutions:

• website globalization
• operator and service manuals
• pharmaceutical IFUs, DFUs
• marketing collateral
• medical device software and help
• scientific and technical articles
• clinical trial protocols
• engineering specifications

Clients
Life sciences companies that look to ForeignExchange for top-quality localization and translation services include:

• Abbott Laboratories(world-wide preferred supplier)
• Arrow International
• Beckman Coulter
• Becton Dickinson
• Bio-Rad Laboratories
• Biogen
• Boston Scientific
• Covance (world-wide preferred supplier)
• Cook
• Davis Vision
• Dräger Medical
• GlaxoSmithKline
• Guidant
• Johnson & Johnson (world-wide preferred supplier)
• Maquet
• Medtronic
• Medrad
• Novartis
• Quintiles (world-wide preferred supplier)
• Siemens Medical
• Respironics Novametrix
• Shire Pharmaceuticals
• Ventana
• Wyeth
• Zimmer
• and many others

For additional information on ForeignExchange's medical translation services, please review our case studies.

ForeignExchange can assist medical device manufacturers with the criteria necessary to obtain the CE mark. We have access to the regulations published by the European Community as well as the specific rules you will need to follow to get your product CE marked. CE marking, and the specifics needed to obtain it, depend upon the classification of your product and country of distribution.

"I am impressed with the translation. Thanks again."

Quality medical translations are no longer optional
Over the past decade, the European Union has issued several directives regulating the CE mark. The following directives govern which medical and in vitro diagnostic devices must be accompanied by what labeling and instructions for use information:

• In vitro diagnostic devices: Directive 98/79/EC of 27 October 1998 (IVDD)
• Medical devices: Directive 93/42/EEC of 14 June 1993 (MDD)

Also included in the directives is the right of each EU member state to dictate the use of each country's local language (these are highlighted within the above PDFs).

For the IVDD, the translation requirement is governed by the following articles:

Article 4, paragraph 4
Article 9, paragraph 11
Annex I, section B, paragraph 8.1

For the MDD, the translation requirement is governed by the following articles:

Article 4, paragraph 4
Article 11, paragraph 12

Can my medical device company obtain a CE mark before translating our documentation and packaging?
No. One of the criteria for obtaining a CE mark for medical devices and similar products is complying with individual country language requirements. In most cases CE requirements mandate that all packaging and instructions for use materials be translated into a national language if the product will be offered for sale in the country.

What if we only want to launch our product in a few European countries initially?
No problem. You can begin by translating for only those markets and simply expand as you go along. However, some companies plan ahead for future language needs. This allows them to get inserts translated (and resolve the associated technical, manufacturing and marketing challenges) up front and save time later. This approach also can save printing and production costs in the long run.

Do you provide a certificate of translation accuracy?
Upon request we will gladly provide a certification of our work. At the conclusion of every project, you will also receive a nonconformance report. Part of our ISO 9002-compliant processes, these reports allow you to raise project-related concerns and they serve as the basis for our corrective/preventive action efforts.

How many people will be assigned to our account?
At the beginning of a relationship, ForeignExchange will assess a client's needs and work volume. Based on this understanding and the service selected, ForeignExchange will dedicate a team of project managers, translators, editors, quality-control linguists, desktop publishing artists and engineers.

Useful Links

Medical Device Consultants, Inc.
Medical Device Consultants, Inc. (MDCI) provides regulatory, clinical and QA consulting services to IVD manufacturers for developing and implementing worldwide regulatory strategies to meet FDA, Canadian and European requirements.

Medical Design Online
Features cutting-edge technical information about the medical device engineering industry.

Going Global: The Challenges of Selling in Multiple Markets
Featured in Medical Design Online, this ongoing series addresses all aspects of selling medical devices abroad—from regulations and packaging to marketing and sales.

The Global Harmonization Task Force (GHTF)
The Global Harmonization Task Force (GHTF) is a voluntary international consortium of public health officials responsible for administering national medical device regulatory systems and representatives from the regulated industry.

MultilingualWebmaster.com
A new web site devoted to promoting "best practices" in multilingual website development and management. Also includes industry news, events and job listings.

Organizations

• Drug Information Association
• Regulatory Affairs Professionals Society
• Medical Marketers Association
• The Global Harmonization Task Force (GHTF)
• Biotechnology Industry Organization
• Radiological Society of North America

The Challenges of Selling in Multiple Markets

A four-part series written by ForeignExchange Translations. Published in Medical Design Online, each article addresses the challenges executives face when selling medical devices abroad and offers advice for taking advantage of the many opportunities foreign markets provide.

Part I
Selling medical devices abroad: develop organizational goals; assemble a team.

Part II
Regulatory affairs and translation management: so many rules, so little time.

Part III
Packaging, labeling and branding in more and more languages.

Part IV
Direct vs. indirect sales, coordination and strategy.