;   Medical Translation Insight: Compliance with new MDD - ForeignExchange Translations

Compliance with new MDD

Compliance with new MDDCompanies 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 software translation.

The updated MDD states that software which 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 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.

Our very own Jason Heaton will present best practices for software translation projects at a Boston-area regulatory affairs conference on July 16, 2009. Racing to Ensure Compliance With the New EU Medical Device Directive Requirements - 2010 Deadline is sponsored by RAPS and will be held at Bentley University in Waltham, MA.

In addition to ForeignExchange, regulatory experts from TUV Rheinland, KEMA, Pleiad, BSI, and others will present. If you are attending, please stop by and say hello.


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