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.
As medical device companies are climbing the learning curve of software localization, many of them have been asking for help on internationalization, agile development and IEC 62304, and, of course, translation/localization. In response, the ForeignExchange team has developed an in-person training session called "Best Practices for Medical Device Software Localization".
Over the next couple of weeks, we are taking this popular seminar coast to coast. Past attendees have told us that this session really helped them develop global-ready software that will work and be effective in any language and culture.
The first event will be in Santa Clara, California on May 3rd and the second will be in Andover, Massachusetts on May 18th. Both complimentary events will be held from 8:30 until 11am with a light breakfast and time for networking.
Medical device professionals can register for the Santa Clara event here: http://info.fxtrans.com/lu20120503-best-practices-for-software-localization-ca/
Registration for the Boston event is also live; register here: http://info.fxtrans.com/lu20120518-best-practices-for-software-localization-boston We are excited to see our readers in Boston and Santa Clara!
For more on software localization and internationalization for medical devices, take a look at the following articles:
- Designing medical device software for MDD compliance
- Medical software ready to take on the world
- A conversation about software localization
ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.