Monday, August 18, 2008

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 new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies were realizing that translation is critical to earning the CE mark.

Manufacturers without 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 diagnostics manufacturers who were dealing with non-English texts for the first time.

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