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Browsing LERO - The Irish Software Research Centre by Subject "MDD"

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Browsing LERO - The Irish Software Research Centre by Subject "MDD"

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  • How amendments to the medical device directive affect the development of medical device software 
    Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine (2011)
    A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in ...
  • Standalone software as an active medical device 
    Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine (Springer-Verlag, 2011)
    With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to ...

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