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The scramble towards MDD 2010 is on!

The scramble towards MDD 2010 is on!For those medical device companies not prepared for the revisions to the EU's Medical Device Directive (MDD, 2007/47/EC), next March may just come in like a lion.

While many of the changes are obvious and easy to accommodate, some are more subtle and require a bit more digging. One of the most challenging components of the new directive is the increased focus on language translation for software and labeling.

For instance, 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 (aka "software localization") is no small feat in a medical device environment. 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.

The 2010 MDD Revisions and What They Mean for Translation is structured to help device companies prepare for the 2010 MDD deadline through a better understanding of its requirements as well as ways to implement best practices into labeling and software translation.

Spend one hour now to get educated, or spend days later arguing with notified bodies, affiliates, and regulatory affairs staff about how to fix your translation processes!


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