Companies are scrambling to meet the new requirements of the 2010 European Medical Device Directive (MDD). One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly. Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

This presentation focuses on the implications of the 2010 MDD for translation. It also covers specific best practices and common pitfalls in software translation and labeling translation, and looks at some of the most common root causes of inaccurate labeling and how to avoid them.

This audio conference covers:

• Impact of the new 2010 Medical Device Directive on translation requirements
• How the translation process works
• Common root causes of inaccurate labeling translations, and how to avoid them
• Best practices for software translations
• How to work with a translation provider to achieve efficient, accurate labeling and software translations

About the speaker:

Jason Heaton is a 10-year veteran of the localization industry, and has seen both sides of the business as a client and vendor. Jason began his career as a technical writer, then moved on to become a project manager at a small translation agency in Minneapolis. After that he joined a large medical device manufacturer, working in both the technical communications and regulatory affairs departments. Jason spent his first three years at ForeignExchange as an account manager, and currently serves as its marketing manager. Jason is a frequent speaker at RAPS and other industry events.

Who should attend?

• Regulatory Affairs Managers
• Regulatory Affairs Associates
• Clinical Managers
• Clinical Research Associates
• Compliance Professionals