This is a guest post from Steve Gotz of the Centre for Next Generation Localisation  (CNGL). 

I am excited to announce that the Centre for Next Generation Localisation (CNGL) will offer a ‘sneak peak’ at the localisation and global content intelligence technologies of the future, when we present our annual Innovation Showcase on 16th November 2011 at Croke Park Convention Centre, Dublin. The showcase will highlight the economic and societal impact of work at the SFI-funded centre, while also presenting a selection of exciting technologies that are ripe for commercialisation via a variety of channels.

Why should you attend?

Technologies such as machine translation, text analytics, speech processing, digital content slicing and adaptive hypermedia are radically changing the way businesses operate on a global scale. Attendees at the Innovation Showcase will have the opportunity to not only view fundamental scientific advances that will be impacting their businesses in the not-to-distant future but also a chance to discuss real-world challenges and opportunities with some of the leading academic minds in the fields.

Our showcases have become particularly fertile grounds for companies looking to solve specific problems or find new product offerings. I look forward to a productive day working with the indigenous community of Multinationals and SMEs to ensure that Ireland remains at the forefront of content management and localisation innovation.

CNGL’s Innovation Showcase is being presented as part of the Innovation Dublin Festival 2011. The event open to the public and free to attend; however spaces are limited. For full details and to register, see www.cngl.ie/showcase

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Software that was not previously classified as a medical device, is now classified as medical device.

Under Directive 2007/47/EC software that was not previously classified as a medical device, is now classified as medical device. A software application may be classified either as a medical device by itself or when it is connected to an active medical device. Organisations need to assess how these changes introduced by Directive 2007/47/EC impact on their specific products, development, quality control procedures and revenue streams.

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The need for state of the art software validation is mandated in Directive 2007/47/EC which states “For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.” In this context “State of the Art” means what is generally accepted as good practice. Developers must now validate software be it integrated or standalone, regardless of device class. IEC 62304 and its aligned standards are harmonised under Directive 2007/47/EC and are seen as a good place to start when validating software.

How will this impact your company when EU customers specify compliance in their tender documents? If you’re an Enterprise Ireland client and have concerns about this, please contact us at gerard.lande@enterprise-ireland.com.

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