Preparing for Increased European Clinical Data and Evaluation Requirements

The newly revised European Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) come into effect on March 21, 2010. There is no transition period, which means that medical devices placed on the market or put into service as of that date will be expected to comply with the revised directives. Some of the most important revisions concern clinical data and clinical evaluation, and the types of adverse events that must be reported if they occur during the clinical study.

In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.

Preparing for Increased European Clinical Data and Evaluation Requirements is being presented by Dr. Maria Donawa, President, of Donawa Lifescience Consulting and airs on Thursday, October 8, 2009. For more details, or to register for this audio conference, please visit our site at www.fxconferences.com

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 Tuesday, October 6, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com