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Browsing LERO - Project partner authors by Subject "ISO/IEC 20000-1"

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Browsing LERO - Project partner authors by Subject "ISO/IEC 20000-1"

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  • Assessing against IEC 80001-1 
    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 ...
  • Development of a process assessment model for assessing medical IT networks against IEC 80001-1 
    MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets, Marion; Renault, Alain (Springer-Verlag, 2012)
    Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness ...
  • Towards a process assessment model for IEC 80001-1 
    MacMahon, Silvana Togneri; Mc Caffery, Fergal; Keenan, Frank (2013)
    Medical Devices are widely used in patient care for both diagnosis and treatment purposes. Typically, modern medical devices are intended to be networked at their point of use. The incorporation of medical devices opens ...
  • Transforming requirements of IEC 80001-1 into an ISO/IEC 15504-2 compliant process reference model and process assessment model 
    MacMahon, Silvana Togneri; Mc Caffery, Fergal; Keenan, Frank (Euro SPI, 2013)
    Efficiencies in patient care can be achieved through interoperability of medical devices. Patient safety is the key concern during the design and manufacture of medical devices with medical devices being subject to stringent ...

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