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Browsing by Author "Mc Caffery, Fergal"

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Browsing by Author "Mc Caffery, Fergal"

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  • Impact of standards on the role and application of traceability in the medical device domain
    Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek (EuroSPI 2012, 2012)
    Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability ...
  • Implementation of a hybrid low overhead assessment method for medical device software development
    Mc Caffery, Fergal (2010)
    The need for software is increasingly growing in the medical device industry. Even though the primary concern of medical device software development is safety, medical device software development organisations are also ...
  • Implementation of a lightweight assessment method for medical device software
    Casey, Valentine; Mc Caffery, Fergal (EuroSPI, 2012)
    This paper outlines the development and implementation of Medi SPICE-Adept. Medi SPICE-Adept is a lightweight assessment method that has been designed for usage with the Medi SPICE software process assessment and improvement ...
  • Improving software risk management in a medical device company
    Mc Caffery, Fergal; Burton, John; Richardson, Ita (IEEE Computer Society, 2009)
    Software Risk Management (RM) within Medical Device (MD) companies is a critical area. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators ...
  • Improving verification & validation in the medical device domain
    Sivakumar, M.S.; Casey, Valentine; Mc Caffery, Fergal; Coleman, Gerry (Springer, 2011)
    The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though ...
  • Integrating agile practices with a medical device software development lifecycle
    Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine; Pikkarainen, Minna (EuroSPI 2012, 2012)
    The rate at which agile software development practices are being adopted is growing rapidly. Agile software development practices and methodologies appear to offer the silver bullet which can solve the problems associated ...
  • Integrating agile practices with plan-driven medical device software development
    Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine (2012)
    The popularity of Agile software development is growing rapidly with an increasing number of projects being developed following Agile methodologies such as Scrum and XP [1]. Research has revealed that following Agile ...
  • The LEGO maturity & capability model approach
    Buglione, Luigi; Gresse von Wangenheim, Christiane; Hauck, Jean Carlo R.; Mc Caffery, Fergal (2011)
    “Maturity model” (MM) (based on Crosby’s original idea) has been one of the main buzzwords over the past 20 years. A variety of MMs have been created in several application domains, from Software Engineering to Contract ...
  • The LEGO strategy: guidelines for a profitable deployment
    Buglione, Luigi; Gresse von Wangenheim, Christiane; Mc Caffery, Fergal; Hauck, Jean Carlo R. (EuroSPI, 2012)
    When dealing with improvements, organizations seek to find a break-even point for their applications as early as possible in order to maximize the return from their investment. However, in some cases such a strategy can ...
  • Med-Adept : a lightweight assessment method for the Irish medical device software industry
    Mc Caffery, Fergal; Casey, Valentine (2010)
    In this paper we describe how a lightweight assessment method was developed to educate Irish software development organisations in relation to becoming medical device software suppliers.
  • MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE
    Mc Caffery, Fergal; Richardson, Ita (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 ...
  • Medical device software traceability.
    Mc Caffery, Fergal; Casey, Valentine; Sivakumar, M.S.; Coleman, Gerry; Donnelly, Peter; Burton, John (Springer Verlag, 2012)
    Software traceability is central to medical device software develop-ment and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have ...
  • 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 ...

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