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Browsing by Author "Mc Caffery, Fergal"

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Browsing by Author "Mc Caffery, Fergal"

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  • Medi SPICE and the development of a process reference model for inclusion in IEC 62304
    Casey, Valentine; Mc Caffery, Fergal (2012)
    The demand for medical device software continues to grow and there is an associated increase in its importance and complexity. This paper discusses medical device software process assessment and improvement. It outlines ...
  • Medi SPICE : an update
    Mc Caffery, Fergal; Dorling, Alec; Casey, Valentine (2010)
    This paper provides an update on the development of a software process assessment and improvement model (Medi SPICE) specifically for the medical device industry. The development of Medi SPICE was launched at the SPICE ...
  • Med-Trace: traceability assessment method for medical device software development
    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 ...
  • The need for a software process improvement model for the medical device industry
    Mc Caffery, Fergal; Coleman, Gerry (Praise Worthy Prize S.r.l., 2007)
    Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict ...
  • Northern Ireland Software Industry Survey
    Mc Caffery, Fergal; Wilkie, F.G.; McFall, Donald (2004)
    This presentation discusses statistical findings obtained from a survey of the state of software development practices within Northern Ireland (NI). The survey was developed and conducted by staff from the Centre for ...
  • Preparing for product derivation: activities and issues
    O'Leary, Pádraig; Richardson, Ita; Mc Caffery, Fergal; Thiel, Steffen (2009)
    Software product lines (SPL) advocates the development of applications by reusing shared software assets across a set of related products. Current approaches to the derivation of products from a product line focuses on ...
  • A process framework for global software engineering teams
    Richardson, Ita; Casey, Valentine; Mc Caffery, Fergal; Burton, John; Beecham, Sarah (Elsevier, 2012)
    .Context: Global Software Engineering (GSE) continues to experience substantial growth and is fundamentally different to collocated development. As a result, software managers have a pressing need for support in how to ...
  • Proposing a knowledge engineering based approach for process capability / maturity models customization
    Hauck, Jean Carlo R.; Gresse von Wangenheim, Christiane; Mc Caffery, Fergal; von Wangenheim, Aldo (2010)
    Software Process Capability/Maturity Models (SPCMMs) are repositories of best practices for software processes suitable for assessing and/or improving processes in software intensive organizations. Yet, although there is ...
  • Proposing an ISO/IEC 15504-2 compliant method for process capability/maturity models customization
    Hauck, Jean Carlo R.; Gresse von Wangenheim, Christiane; Mc Caffery, Fergal; Buglione, Luigi (Association for Computing Machinery, 2011)
    The customization of software process capability/maturity models (SPCMMs) to specific domains/sectors or development methodologies represents one of the most discussed and applied trends in ICT organizations. Nonetheless, ...
  • Risk management capability model (RMCM) for the development of medical device software
    Mc Caffery, Fergal; Richardson, Ita; Burton, John (Springer Verlag, 2009)
    Failure of medical device (MD) software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators penalise MD manufacturers who do not demonstrate that sufficient attention ...
  • The software development culture of Northern Ireland
    McFall, Donald; Mc Caffery, Fergal; Wilkie, F.G. (2004)
    The Northern Ireland (NI) software development survey was developed by the Centre for Software Process Technologies (CSPT). CSPT was established in September 2002 and is jointly funded by Invest Northern Ireland (an economic ...
  • A software process development,assessment and improvement framework,for the medical device industry
    Mc Caffery, Fergal; Donnelly, Peter; Dorling, Alec; Wilkie, F.G. (2004)
    This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly ...
  • Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive
    Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine (The Institution of Engineering and Technology, 2012)
    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 ...
  • A software risk management capability model for medical device software
    Burton, John (University of Limerick, 2008)
    The Medical Device industry is currently one of the fastest growing industries in the world and a guarantee of the integrity of medical device software has become increasingly important. Failure of the software can have ...
  • Software risk management in medical device systems
    Burton, John; Mc Caffery, Fergal; Richardson, Ita (2008)
  • Tailoring software process capability/maturity models for telemedicine systems
    Gresse von Wangenheim, Christiane; von Wangenheim, Aldo; Hauck, Jean Carlo R.; Mc Caffery, Fergal; Buglione, Luigi (2012)
    Developing high-quality asynchronous store-and-forward telemedicine systems (ASFTSs) remains a challenge. However, there is no accepted understanding as to what are the important quality characteristics for this type of ...
  • Towards agile product derivation in software product line engineering
    O'Leary, Pádraig; Mc Caffery, Fergal; Richardson, Ita; Thiel, Steffen (2009)
    Software Product Lines (SPL) and Agile practices have emerged as new paradigms for developing software. Both approaches share common goals; such as improving productivity, reducing time to market, decreasing development ...
  • Traceability-why do it?
    Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek (Springer-Verlag, 2012)
    Traceability of software artifacts, from requirements to design and through implementation and quality assurance, has long been promoted by the research and expert practitioner communities. However, evidence indicates that, ...
  • Understanding the relationships within the Medi SPICE framework
    Flood, Derek; Mc Caffery, Fergal; Casey, Valentine (IARIA International Academy, Research and Industry Association, 2012)
    Regulated domains, such as medical device software development, require organisations to have specific processes in place in order to secure regulatory approval. Software process improvement initiatives, such as Medi ...
  • Verification & validation in medi spice
    Sivakumar, M.S.; Casey, Valentine; Mc Caffery, Fergal; Coleman, Gerry (2011)
    Effective verification and validation are central to medical device software de-velopment and are essential for regulatory approval. Although guidance is available in mul-tiple standards in the medical device software ...

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