The 2010 MDD Revisions and What They Mean for Translation

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.

The 2010 MDD Revisions and What They Mean for Translation is being presented by Jason Heaton, with ForeignExchange Translations and airs on Wednesday, February 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

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.

Software as a Device: What You Need to Know About the New MDD

The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.

It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.

Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site www.fxconferences.com