The $9 billion U.S. in vitro diagnostics (IVD) industry is 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 are realizing that translation is critical to earning the CE mark.
Manufacturers that lack effective plans for complying with the language requirements of the directive risk losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews present new challenges for the majority of diagnostics manufacturers who are dealing with non-English texts for the first time.
CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements was presented by Andres Heuberger, President, with ForeignExchange Translations, Inc. and was previously recorded. For more details, or to download this conference please visit our site at www.fxconferences.com
