The Experts below are selected from a list of 11196 Experts worldwide ranked by ideXlab platform

Aldo Dagnino - One of the best experts on this subject based on the ideXlab platform.

  • An evolutionary lifecycle model with Agile practices for software development at ABB
    Eighth IEEE International Conference on Engineering of Complex Computer Systems 2002. Proceedings., 2002
    Co-Authors: Aldo Dagnino
    Abstract:

    Current software environments face increased pressure to develop products under evolving requirements, changing technologies, scarce human resources, and the need to develop high quality applications. ABB has similar pressures, especially as the organization embraces the Industrial IT initiative that aims at the development of interoperable and intelligent products. A new generation of software development lifecycle models has emerged lately called "Agile" and they embrace change, reduce development cycle time, and attempt a useful compromise between no process and too much process. The Agile development in Evolutionary Prototyping Technique (ADEPT) presented in this paper, was developed at the ABB US Corporate Research Center, and incorporates "Agile" practices to streamline the technology development lifecycle of Industrial IT products.

Derek Flood - One of the best experts on this subject based on the ideXlab platform.

  • a traceability process assessment model for the medical device domain
    European conference on Software Process Improvement, 2014
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Miklos Biro, Derek Flood
    Abstract:

    Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as impact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software.

  • medical device standards requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
    Computer Standards & Interfaces, 2013
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
    Abstract:

    Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (Med-Trace), which we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

  • implementation of traceability best practices within the medical device domain
    2013
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
    Abstract:

    Requirements validation, compliance verification and impact analysis are important activities that are performed during the software development lifecycle. Traceability of requirements through the software development lifecycle (SDLC) is essential in the development of safety critical software. Organisations such as the Food and Drug Administration and the Federal Aviation Authority in the United States require traceability as part of their approval process. However, despite its criticality there is extensive digression in the practices and usefulness of traceability across development projects. Many projects’ traceability efforts are simply focused on satisfying regulations and do not leverage the many benefits of traceability. Traceability, if fully implemented is an important tool for managing system development and there are a number of published best practices to help companies with this implementation. By means of a literature review we record a list of the commonly accepted best practices for traceability implementation. Furthermore, through interviews with two medical device companies we report that a number of these practices are unfamiliar to these companies and why an even greater number of these practices are not applied.

Fergal Mc Caffery - One of the best experts on this subject based on the ideXlab platform.

  • a traceability process assessment model for the medical device domain
    European conference on Software Process Improvement, 2014
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Miklos Biro, Derek Flood
    Abstract:

    Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as impact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software.

  • medical device standards requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
    Computer Standards & Interfaces, 2013
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
    Abstract:

    Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (Med-Trace), which we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

  • implementation of traceability best practices within the medical device domain
    2013
    Co-Authors: Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
    Abstract:

    Requirements validation, compliance verification and impact analysis are important activities that are performed during the software development lifecycle. Traceability of requirements through the software development lifecycle (SDLC) is essential in the development of safety critical software. Organisations such as the Food and Drug Administration and the Federal Aviation Authority in the United States require traceability as part of their approval process. However, despite its criticality there is extensive digression in the practices and usefulness of traceability across development projects. Many projects’ traceability efforts are simply focused on satisfying regulations and do not leverage the many benefits of traceability. Traceability, if fully implemented is an important tool for managing system development and there are a number of published best practices to help companies with this implementation. By means of a literature review we record a list of the commonly accepted best practices for traceability implementation. Furthermore, through interviews with two medical device companies we report that a number of these practices are unfamiliar to these companies and why an even greater number of these practices are not applied.

  • Integrating Agile Practices with a Medical Device software development lifecycle
    2012
    Co-Authors: Martin Mc Hugh, Fergal Mc Caffery, Valentine Casey, Minna Pikkarainen
    Abstract:

    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 with following plan driven software development lifecycles. Agile software development practices offer the possibility of achieving lower development costs, increased efficiency and improved software quality. However, there is currently a low rate of publicly available information that suggests there is widespread adoption of agile practices within the medical device software domain. This is largely due to the fact that software developed for medical devices includes challenges not faced when developing non safety critical software. As a result of these challenges, medical device software is typically developed using plan driven software development lifecycles. However, such lifecycles are quite rigid and cannot accommodate changes easily. Previous research has revealed that medical device software development projects can benefit from adopting agile practices whilst still maintaining the discipline associated with following plan driven development lifecycles. This paper outlines the challenges faced by developers when developing medical device software and how shortcomings in both agile and plan driven approaches can be resolved by following a mixed method approach to medical device software development.

Fergal Mccaffery - One of the best experts on this subject based on the ideXlab platform.

  • agile is it suitable for medical device software development
    International Conference on Software Process Improvement and Capability Determination, 2016
    Co-Authors: Fergal Mccaffery, Kitija Trektere, Ozden Ozcantop
    Abstract:

    Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.

  • an agile implementation within a medical device software organisation
    International Conference on Software Process Improvement and Capability Determination, 2014
    Co-Authors: Martin Mchugh, Fergal Mccaffery, Garret Coady
    Abstract:

    Three surveys conducted over a 6 year period revealed that medical device software organisations have difficulties in the area of requirements management, namely accommodating changes in requirements. Medical device software is traditionally developed in accordance with a plan driven software development lifecycle (SDLC). These SDLCs are rigid and inflexible to changes once the requirements management stage has been completed. Agile methods are gaining momentum in non-regulated industries but as of yet, the adoption of these methods in regulated industries such as the medical device software domain remains low. This study presents an implementation of agile methods within a medical device software development organisation based in Ireland. This implementation involved integrating agile practices with a traditional plan driven SDLC. Upon completing this implementation within a medical device software development project, the organisation identified cost savings and a reduction in the rework required when introducing a change in requirements.

  • standalone software as an active medical device
    International Conference on Software Process Improvement and Capability Determination, 2011
    Co-Authors: Martin Mchugh, Fergal Mccaffery, Valentine Casey
    Abstract:

    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 be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way.

Mario Piattini - One of the best experts on this subject based on the ideXlab platform.

  • applying a security requirements engineering process
    European Symposium on Research in Computer Security, 2006
    Co-Authors: Daniel Mellado, Eduardo Fernandezmedina, Mario Piattini
    Abstract:

    Nowadays, security solutions are mainly focused on providing security defences, instead of solving one of the main reasons for security problems that refers to an appropriate Information Systems (IS) design. In fact, requirements engineering often neglects enough attention to security concerns. In this paper it will be presented a case study of our proposal, called SREP (Security Requirements Engineering Process), which is a standard-centred process and a reuse-based approach which deals with the security requirements at the earlier stages of software development in a systematic and intuitive way by providing a security resources repository and by integrating the Common Criteria into the software development lifecycle. In brief, a case study is shown in this paper demonstrating how the security requirements for a security critical IS can be obtained in a guided and systematic way by applying SREP.