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Browsing Faculty of Science and Engineering by Subject "ISO/IEC 15504 – process assessment"

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Browsing Faculty of Science and Engineering by Subject "ISO/IEC 15504 – process assessment"

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  • MacMahon, Silvana Togneri; Mc Caffery, Fergal; Keenan, Frank (Springer, 2013)
    IEC 80001-1 is a risk management standard that addresses the risks associated with the incorporation of a medical device into an IT network. Our research in the area of IEC 80001-1 has to date been focused on the development ...
  • MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets, Marion; Renault, Alain (2013)
    Medical devices are designed and produced subject to various standards. These standards are recognized by the regulatory authorities within the region in which they are going to be marketed. Traditionally medical devices ...

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