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Industry Reports
Labeling: The Path to Global Market Clearance — Learn about methods commonly used for market clearance, commonly encountered labeling related issues, recommendations and helpful hints, and the industry’s best practices. Understanding Directive 2007/47/EC — 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 you need to do to be compliant before March 2010, and how we can help schedule your transition to full compliance. European Language Requirements for Medical Devices and Pharmaceuticals — Learn more about what languages are required for marketing medical devices and pharmaceuticals in Europe plus additional international language requirements. How to Choose a Translation Provider — Selecting the right medical translation partner is perhaps the most important step in the successful completion of a translation project. This report will address the best practices you should consider when selecting an industry leading medical translation company. To Translate or Not To Translate per Directive 2007/47/EC — Forget about conflicting advice and confusing guidance. Brian Ludovico, senior technical manager and certification officer at TÜV Rheinland's Boxborough, MA, office explains his position on what needs to be done and what he considers nonconformities with regards to translating software scripts (GUI menus, dialog boxes, and error and status messages). Learn what to do in order to be compliant with Directive 2007/47/EC and avoid losing your CE Mark! Asian Language Requirements for Medical Devices and Pharmaceuticals — Learn more about what languages are required for marketing medical devices and pharmaceuticals in Asia plus additional international language requirements. Best Practices for Consolidating & Merging Your Translation Memories from Multiple Vendors: A Case Study — In this article you will learn methods to merge, consolidate, and clean-up your existing translation memories from multiple sources to avoid conflicts and erroneous terminology. |
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