Lero researcher Dr Fergal McCaffery (pictured) of Dundalk Institute of Technology has completed the medical device section of a major €4.6 million EU software research programme. The EU Charter programme is designed to speed and reduce the cost of certification of software and so enhance European competitiveness.
"The fact that Ireland was selected to provide the medical device part of this important international programme is a tribute to the country’s expertise in this area through researchers like Dr McCaffery," said Prof Mike Hinchey, director, Lero – the Irish Software Engineering Research Centre.
"This recognition by Europe further enhances Ireland’s attractiveness as a location for the rapidly growing medical device sector. Through its researchers in the Dundalk Institute of Technology and elsewhere, Lero is increasingly consulting with indigenous and international medical device companies."
The EU Charter programme emphasises the growing importance of software which is embedded in critical applications from air travel to medicine. Because of this there is a need to ensure that systems remain safe despite their increasing complexity and interconnectedness. The research programme overview states that failure to do so, "could cost loss of life, environmental harm or significant financial loss".
Lero’s research used a heart rate monitor as an example of how to develop certification internationally for all types of medical devices. Dr McCaffery said: "Under new EU and US regulations, medical devices are no longer treated solely as hardware. Now the software involved must comply with a new standard known as IEC 62304. This has huge implications for the industry and our research came up with a tool kit which will enable medical device companies to develop products in accordance with the latest international standards."
Lero is funded by Science Foundation Ireland and other Irish and international funding agencies.
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