Friday, July 4, 2008

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

Back in 2002, the $9 billion U.S. in vitro diagnostics (IVD) industry was ill prepared to meet the strict new regulations contained in the European Union's IVD Directive. IVD manufacturers were realizing that translation is critical to earning the CE mark.

Manufacturers that lacked effective plans for complying with the language requirements of the directive risked losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews presented new challenges for the majority of in vitro diagnostics manufacturers who were dealing with non-English texts for the first time.

This audio conference is presented by Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.