The medical device section of a €4.6m EU software research programme has been completed by researchers at Dundalk Institute of Technology as part of Lero, the Irish Software Engineering Research Centre. The researchers created a tool kit to allow medical device companies to develop products in accordance with the latest international standards.
Lero researcher Dr Fergal McCaffery from Dundalk Institute of Technology led the medical device research.
Under the direction of McCaffery, the researchers used a heart rate monitor as an example of how to develop certification internationally for all types of medical devices.
In all, McCaffery said that eight researchers were involved in the project. And the implications of this medical device research?
"We’ve developed a suite of tools for organisations that are developing embedded safety-critical software for the four domains of surveillance, automotive, aerospace and medical devices," he explained.
"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," said McCaffery.
"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," he said.
The overall €4.6m EU software programme has been designed to speed and reduce the cost of certification of software in order to enhance European competitiveness.
Lero’s director Prof Mike Hinchey said the fact Ireland was chosen to carry out the medical device aspect of the programme was testament to the country’s expertise in the area.
"This recognition by Europe further enhances Ireland’s attractiveness as a location for the rapidly growing medical-device sector," he said.
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