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Do no harm: getting medical software right

According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device.

It doesn't matter if the software is integrated into the actual device or a stand-alone product. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Software validation will also be an Essential Requirement under the MDD.

Annex I of Essential Requirement 12.1 now states that software must be validated, taking into account the principles of development lifecycle, risk management, validation, and verification. Given this new attention on software by global regulators, proper medical software localization is now even more important.

ForeignExchange's own Sandra LaBrasca and Jason Heaton co-authored an article entitled, "Do No Harm: The Importance of Getting Medical Translation Right" for the August issue of MultiLingual. Download a PDF of the article from our web site.

ForeignExchange localizes software applications and training programs for medical device and pharmaceutical companies. For specialized medical translation and software localization services, contact us today!


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