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Author = Flood, Derek;
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Displaying Results 1 - 25 of 38 on page 1 of 2
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A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps
(2014)
Flood, Derek; McCaffery, Fergal; Regan, Gilbert; Casey, Valentine
A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps
(2014)
Flood, Derek; McCaffery, Fergal; Regan, Gilbert; Casey, Valentine
Abstract:
For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify “what” must be achieved without specifying “how” this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medical device manufacturers. In this work we present a concept for a Software Process Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap fro...
http://eprints.dkit.ie/408/
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A critical evaluation of a methodology for the generation of software process improvement roadmaps
(2014)
Flood, Derek; Mc Caffery, Fergal; Regan, Gilbert; Casey, Valentine
A critical evaluation of a methodology for the generation of software process improvement roadmaps
(2014)
Flood, Derek; Mc Caffery, Fergal; Regan, Gilbert; Casey, Valentine
Abstract:
For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify “what” must be achieved without specifying “how” this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medi-cal device manufacturers. In this work we present a concept for a Software Pro-cess Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap f...
http://hdl.handle.net/10344/4390
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A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
Abstract:
Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives or-ganisations undergo an assessment and then embark on a software process im-provement program to improve their existing processes to meet a desired target. These programs can be improved by the use of process improvement roadmaps that are tailored to the organisation and are usually non-transferrable. Within regulated domains, such as the medical device industry, adherence to interna-tional standards must be achieved before products can be placed on the market. This work proposes the use of software process improvement roadmaps to assist organisations achieve compliance with medical device standards. These pro-posed roadmaps will be generic in nature to meet the requirements of the stand-ard, but will be subsequently tailored to meet the specific requirements of an individual organisation. In this paper we introduce the concept of the softwa...
http://hdl.handle.net/10344/3883
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A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with ISO 62366
(2013)
Flood, Derek; McCaffery, Fergal; Casey, Valentine; Regan, Gilbert
A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with ISO 62366
(2013)
Flood, Derek; McCaffery, Fergal; Casey, Valentine; Regan, Gilbert
Abstract:
Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives organisations undergo an assessment and then embark on a software process improvement program to improve their existing processes to meet a desired target. These programs can be improved by the use of process improvement roadmaps that are tailored to the organisation and are usually non-transferrable. Within regulated domains, such as the medical device industry, adherence to international standards must be achieved before products can be placed on the market. This work proposes the use of software process improvement roadmaps to assist organisations achieve compliance with medical device standards. These proposed roadmaps will be generic in nature to meet the requirements of the standard, but will be subsequently tailored to meet the specific requirements of an individual organisation. In this paper we introduce the concept of the software pr...
http://eprints.dkit.ie/608/
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A roadmap to implement a quality management system
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine
A roadmap to implement a quality management system
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine
Abstract:
In recent years the proportion and complexity of software in medical devices has increased considerably. This has presented an opportunity for software development organisations to expand into the medical device domain. Due to the high level of risk associated with medical devices, strict regulations must be adhered to in order to market such products. One key aspect of these regulations is the necessity to have in place a Quality Management System to help ensure an organisations’ ability to consistently meet customer and regulatory requirements. This paper presents a roadmap which can be used to assist organisations, wishing to develop medical device software to implement a Quality Management System.
http://hdl.handle.net/10344/3125
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A roadmap to ISO 14971 implementation
(2015)
Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek
A roadmap to ISO 14971 implementation
(2015)
Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek
Abstract:
Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap.
http://eprints.dkit.ie/547/
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A Software Process Improvement Roadmap for IEC 62304: an Expert Review
(2018)
Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal
A Software Process Improvement Roadmap for IEC 62304: an Expert Review
(2018)
Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal
Abstract:
Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high l...
http://eprints.dkit.ie/626/
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A Traceability Process Assessment Model for the Medical Device Domain
(2014)
Regan, Gilbert; Biro, Miklos; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
A Traceability Process Assessment Model for the Medical Device Domain
(2014)
Regan, Gilbert; Biro, Miklos; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
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. Within the medical device domain, as in other safety critical domains, software must provide reliability, safety and security because failure to do so can lead to injury or death. However, despite its criticality most software systems don’t employ explicit traceability between artefacts. Numerous barriers hamper the effective implementation of traceability such as cost, complexity of relationship between artefacts, calculating a return on investment, different stakeholder viewpoints, lack of awareness of traceability and a lack of guidance as to how...
http://eprints.dkit.ie/407/
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A traceability process assessment model for the medical device domain
(2014)
Regan, Gilbert; Biro, Miklos; Mc Caffery, Fergal; McDaid, Kevin; Flood, Derek
A traceability process assessment model for the medical device domain
(2014)
Regan, Gilbert; Biro, Miklos; Mc Caffery, Fergal; McDaid, Kevin; Flood, Derek
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 im-pact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, as in other safety critical domains, soft-ware must provide reliability, safety and security because failure to do so can lead to injury or death. However, despite its criticality most software systems don’t employ explicit traceability between artefacts. Numerous barriers hamper the effective implementation of traceability such as cost, complexity of relation-ship between artefacts, calculating a return on investment, different stakeholder viewpoints, lack of awareness of traceability and a lack of guidance as to ...
http://hdl.handle.net/10344/4389
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Assessing traceability — practical experiences and lessons learned
(2015)
Regan, Gilbert; Biro, Miklos; Flood, Derek; McCaffery, Fergal
Assessing traceability — practical experiences and lessons learned
(2015)
Regan, Gilbert; Biro, Miklos; Flood, Derek; McCaffery, Fergal
Abstract:
Most existing software systems that lack explicit traceability links between artefacts, or if implemented, are often not leveraged to take advantage of the information it can provide to a development or validation team. Within the medical device domain, as in other safety critical domains, regulation normally requires such systems that are certified before entering service. This involves submission of a safety case (a reasoned argument that the system is acceptably safe) to the regulator. A safety case should include evidence that the organisation has established effective software development processes. At the heart of such processes, they must incorporate traceability. However, numerous barriers such as a lack of awareness of traceability and a lack of guidance as to how to implement traceability hamper its effective implementation. In this paper, we address the lack of guidance on traceability implementation by presenting our experience of developing and trialling a traceability ...
http://eprints.dkit.ie/607/
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Creation of an IEC 62304 compliant Software Development Plan
(2016)
Rust, Peter; Flood, Derek; McCaffery, Fergal
Creation of an IEC 62304 compliant Software Development Plan
(2016)
Rust, Peter; Flood, Derek; McCaffery, Fergal
Abstract:
Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical Device Software—Software Life Cycle Processes, defines the processes that are required in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out but does not state how. In a review of a number of such organizations, it was found that the development of a software development plan proved to be a difficult task. In this work we have created a software development plan template to assist organizations with this arduous task. The software development plan template will be validated with these organizations as part of the future work.
http://eprints.dkit.ie/549/
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Evaluation of an Intelligent Assistive Technology for Voice Navigation of Spreadsheets
(2008)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal; Bishop, Brian
Evaluation of an Intelligent Assistive Technology for Voice Navigation of Spreadsheets
(2008)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal; Bishop, Brian
Abstract:
An integral part of spreadsheet auditing is navigation. For sufferers of Repetitive Strain Injury who need to use voice recognition technology this navigation can be highly problematic. To counter this the authors have developed an intelligent voice navigation system, iVoice, which replicates common spreadsheet auditing behaviours through simple voice commands. This paper outlines the iVoice system and summarizes the results of a study to evaluate iVoice when compared to a leading voice recognition technology.
http://eprints.dkit.ie/117/
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Impact of Standards on the Role and Application of Traceability in the Medical Device Domain
(2012)
Regan, Gilbert; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
Impact of Standards on the Role and Application of Traceability in the Medical Device Domain
(2012)
Regan, Gilbert; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
Abstract:
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 process is required. Hence traceability is central to medical device software development. It is also an essential requirement for regulatory approval. The necessity for traceability is reinforced by the medical device standards and guidelines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings obtained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations.
http://eprints.dkit.ie/244/
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Impact of standards on the role and application of traceability in the medical device domain
(2012)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
Impact of standards on the role and application of traceability in the medical device domain
(2012)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
Abstract:
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 process is required. Hence traceability is central to medical device software de-velopment. It is also an essential requirement for regulatory approval. The ne-cessity for traceability is reinforced by the medical device standards and guide-lines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings ob-tained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations.
http://hdl.handle.net/10344/2526
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Implementation of traceability best practices within the medical device domain
(2013)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
Implementation of traceability best practices within the medical device domain
(2013)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
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 b...
http://hdl.handle.net/10344/3446
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Implementation of traceability best practices within the medical device domain.
(2013)
Flood, Derek; McDaid, Kevin; Mc Caffrey, Fergal; Regan, Gilbert
Implementation of traceability best practices within the medical device domain.
(2013)
Flood, Derek; McDaid, Kevin; Mc Caffrey, Fergal; Regan, Gilbert
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 b...
http://eprints.dkit.ie/604/
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Intelligent Voice Navigation of Spreadsheets: An Empirical Evaluation
(2008)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal; Bishop, Brian
Intelligent Voice Navigation of Spreadsheets: An Empirical Evaluation
(2008)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal; Bishop, Brian
Abstract:
Interaction with software systems has become second nature to most computer users, however when voice recognition is introduced, this simple procedure becomes quite complex. To reduce this complexity for spreadsheet users, the authors have developed an intelligent voice navigation system called iVoice. This paper outlines the iVoice system and details an experiment that was conducted to determine the efficiency of iVoice when compared to a leading voice recognition technology.
http://eprints.dkit.ie/111/
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Investigation of Traceability within a Medical Device Organization
(2013)
McDaid, Kevin; McCaffery, Fergal; Regan, Gilbert; Flood, Derek
Investigation of Traceability within a Medical Device Organization
(2013)
McDaid, Kevin; McCaffery, Fergal; Regan, Gilbert; Flood, Derek
Abstract:
Requirements traceability helps to ensure software quality. It supports quality assurance activities such as impact analysis, regression test selection, compliance verification and validation of requirements. Its implementation has long been promoted by the research and expert practitioner communities. However, evidence indicates that few software organizations choose to implement traceability processes, in the most part due to cost and complexity issues. Organizations operating within the safety critical domains are mandated to implement traceability, and find the implementation and maintenance of an efficient and compliant traceability process a difficult and complex issue. Through interviews with a medical device SME, this paper seeks to determine how traceability is implemented within the organization, the difficulties it faces in implementing traceability, how compliant it is with the medical device standards and guidelines, and what changes could be made to improve the efficie...
http://eprints.dkit.ie/603/
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MeD UD – A process reference model for usability design in medical devices
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
MeD UD – A process reference model for usability design in medical devices
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
Abstract:
A critical component to the success of software systems is the incor-poration of the end user. Ensuring that the end user can use the system effec-tively and efficiently is an important consideration. Failure to do this can lead to user error which in turn can have serious or even fatal consequences. To ad-dress this issue in the medical domain, where the risk to patient and user safety is quite high, a number of standards and guidance documents promote the use of Human Factors and Usability Engineering techniques during the develop-ment of devices. In this paper we introduce MeD UD (Medical Device Usabil-ity Design) – A Process Reference Model (PRM) for evaluating usability engi-neering in the medical device domain. Through a process assessment utilising the MeD UD PRM, medical device organisations can improve their usability design processes to achieve more usable products, reduce the risks associated with user errors and efficiently meet the medical device regulatory require-ments.
http://hdl.handle.net/10344/3881
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Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
(2013)
McCaffery, Fergal; Regan, Gilbert; Flood, Derek; McDaid, Kevin
Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
(2013)
McCaffery, Fergal; Regan, Gilbert; Flood, Derek; McDaid, Kevin
Abstract:
Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist med...
http://eprints.dkit.ie/602/
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Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
(2013)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
(2013)
Regan, Gilbert; Mc Caffery, Fergal; Mc Daid, Kevin; Flood, Derek
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 obtain...
http://hdl.handle.net/10344/3445
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Mobile medical app development with a focus on traceability
(2017)
McCaffery, Fergal; Kitija, Trektere; Regan, Gilbert; Flood, Derek; Lepmets, Marion
Mobile medical app development with a focus on traceability
(2017)
McCaffery, Fergal; Kitija, Trektere; Regan, Gilbert; Flood, Derek; Lepmets, Marion
Abstract:
Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mob...
http://eprints.dkit.ie/598/
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MobiTest: a cross-platform tool for testing mobile applications
(2012)
Bayley, Ian; Flood, Derek; Harrison, Rachel; Martin, Clare
MobiTest: a cross-platform tool for testing mobile applications
(2012)
Bayley, Ian; Flood, Derek; Harrison, Rachel; Martin, Clare
Abstract:
Testing is an essential part of the software development lifecycle. However, it can cost a lot of time and money to perform. For mobile applications, this problem is further exacerbated by the need to develop apps in a short time-span and for multiple platforms. This paper proposes MobiTest, a cross-platform automated testing tool for mobile applications, which uses a domain-specific language for mobile interfaces. With it, developers can define a single suite of tests that can then be run for the same application on multiple platforms simultaneously, with considerable savings in time and money.
http://hdl.handle.net/10344/2794
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NLP-SIR: A Natural Language Approach for Spreadsheet Information Retrieval
(2001)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal
NLP-SIR: A Natural Language Approach for Spreadsheet Information Retrieval
(2001)
Flood, Derek; McDaid, Kevin; McCaffery, Fergal
Abstract:
Spreadsheets are a ubiquitous software tool, used for a wide variety of tasks such as financial modelling, statistical analysis and inventory management. Extracting meaningful information from such data can be a difficult task, especially for novice users unfamiliar with the advanced data processing features of many spreadsheet applications. We believe that through the use of Natural Language Processing (NLP) techniques this task can be made considerably easier. This paper introduces NLP-SIR, a Natural language interface for spreadsheet information retrieval. The results of a recent evaluation which compared NLP-SIR with existing Information retrieval tools are also outlined. This evaluation has shown that NLP-SIR is a more effective method of spreadsheet information retrieval.
http://eprints.dkit.ie/112/
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Research Findings from an Industrial Trial of a Traceability Assessment and Implementation Framework
(2016)
McCaffery, Fergal; Flood, Derek; Regan, Gilbert
Research Findings from an Industrial Trial of a Traceability Assessment and Implementation Framework
(2016)
McCaffery, Fergal; Flood, Derek; Regan, Gilbert
Abstract:
Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist med...
http://eprints.dkit.ie/601/
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