University of Limerick Institutional Repository

Browsing by Author "IGERDF"

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Browsing by Author "IGERDF"

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  • Casey, Valentine; Mc Caffery, Fergal (2011)
    Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure ...
  • Cawley, Oisín; Richardson, Ita; Wang, Xiaofeng (2011)
    Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development ...
  • 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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