Valentine (Val) Casey | University of Limerick (original) (raw)

Books by Valentine (Val) Casey

Today software development has truly become a globally sourced commodity. This trend has been fac... more Today software development has truly become a globally sourced commodity. This trend has been facilitated by the availability of highly skilled software professionals in low cost locations in Eastern Europe, Latin America and the Far East. Organisations endeavouring to leverage the opportunities this provides and to avail of the benefits of establishing operations close to emerging markets have embraced this strategy in large numbers. Software testing plays a key role in delivering high quality products and is a labour intensive, complex and expensive activity. In the context of Global Software Development (GSD) to date testing has been perceived as a well defined task that is relatively straightforward and lends itself to being outsourced or offshored. This volume considers this specific topic and demonstrates that testing in a GSD environment is not a simple activity. It is prone to be negatively impacted by all the factors associated with distributed software development.This work also provides practical solutions which can be utilised to address these important issues. While the primary focus of this work is software testing it is also the culmination of 10 years research by the author in the area of GSD. During this period he has considered all aspects of the software development life cycle. This experience and knowledge has been incorporated into this volume. It is therefore relevant to note this work is of value to the wider software community not just to those interested in testing. It specifically considers the establishment of virtual teams and their efficient and effective operation. Therefore this book has relevance to all those interested in implementing or improving a GSD strategy. Its particular strengths are that while it is a scholarly work it is industry based and practical

Papers by Valentine (Val) Casey

IGI Global eBooks, 2010

Given the requirement for software engineering graduates to operate in Global Software Developmen... more Given the requirement for software engineering graduates to operate in Global Software Development (GSD) environments, educators need to develop teaching methods to enhance and instill GSD knowledge in their students. In this paper, we discuss two projects that provided students with a first-hand learning experience of working within GSD teams. One project was with Siemens Corporate Research, whose focus was to shadow the development of a real-life GSD project. The second project, whose focus was virtual team software testing, was carried out in collaboration with Ball State University. In parallel with these projects we undertook qualitative research during which we analyzed students' own written reflections and face-to-face interviews that focused on their learning experiences in these contexts. We identified three specific forms of learning which had taken place: pedagogical, pragmatic and the acquisition of specific globally distributed knowledge. Our findings confirm that mimicking real work settings has educational benefits for problem-based learning environments.

Shuili Fadian Xuebao, 2013

Since 2010, two significant international regulations regarding medical device developme... more Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III‐high risk to Class I‐ low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve...

On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data... more On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In add...

Software development has become a globally sourced commodity. Software development processes such... more Software development has become a globally sourced commodity. Software development processes such as requirements elicitation, development of components and maintenance tasks are often distributed across sites and countries. This research paper focuses on the distribution of the testing process, which is not a straightforward task. The research presented here has examined the management of virtual teams within a distributed testing environment in two multi-national companies in Ireland. This has elicited many issues over and above the ‘socio-cultural’ issues so often discussed. Some of the difficulties encountered include language differences, use of communication tools, different process maturity levels, tools and standards, technical ability and knowledge management. Apart from the management of the testing process, we are also considering the technical issues involved in the global distribution of testing. A related study is being undertaken with teams of students from Masters cl...

Proceedings of the 7th International Conference on Software Paradigm Trends, 2012

The demand for medical device software continues to grow and there is an associated increase in i... more 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, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software-Software life cycle processes. IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union. This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE. Finally the timeline for the release of the full Medi SPICE model is provided.

Journal of the Brazilian Computer Society, 2010

Globally distributed information systems development has become a key strategy for large sections... more Globally distributed information systems development has become a key strategy for large sections of the software industry. This involves outsourcing projects to third parties or offshoring development to divisions in remote locations. A popular approach when implementing these strategies is the establishment of virtual teams. The justification for embarking on this approach is to endeavor to leverage the potential benefits of labor arbitrage available between geographical locations. When implementing such a strategy organizations must recognize that virtual teams operate differently to collocated teams, therefore, they must be managed differently. These differences arise due to the complex and collaborative nature of information systems development and the impact distance introduces. Geographical, temporal, cultural, and linguistic distance all negatively impact on coordination, cooperation, communication, and visibility in the virtual team setting. In these circumstances, it needs...

ACM Inroads, 2010

Professional software development is normally team based and is recognised as a socio-technical a... more Professional software development is normally team based and is recognised as a socio-technical activity. In recent years, this has been coupled with the increasing popularity of outsourcing and offshoring software development. These are two significant issues, which need to be considered and recognized. As educators, it is important that we prepare our students, at both the undergraduate and postgraduate level to make informed and meaningful contributions to the industry they plan to enter. To facilitate this we need to consider providing modules that outline the benefits and problems associated with globally distributed software development. As research has identified, a key element of any such module is the importance and impact that cultural diversity plays. To facilitate understanding in this area, students can benefit from knowledge of the literature on culture. This can provide essential information which allows them to understand the broader aspects of this important topic. ...

Journal of Software: Evolution and Process, 2013

Non-safety critical software developers have been reaping the benefits of adopting agile practice... more Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as: being contradictory to regulatory requirements; insufficient coverage of risk management activities and the lack of up-front planning. In addition, a comparison is performed between the perceived and actual barriers. Based upon the findings of the literature review and survey, it emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in.

Communications in Computer and Information Science, 2011

Effective verification and validation are central to medical device software development and are ... more Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

Communications in Computer and Information Science, 2011

The benefits of effective verification and validation activities in the medical device domain inc... more 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 there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper highlights three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains.

Communications in Computer and Information Science, 2011

Traceability is central to medical device software development and essential for regulatory appro... more Traceability is central to medical device software development and essential for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This is difficult to achieve due to the lack of specific guidance which the medical device regulations and standards provides. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we briefly outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry.

Communications in Computer and Information Science, 2012

As the importance and complexity of medical device software continues to increase there is growin... more As the importance and complexity of medical device software continues to increase there is growing demand for effective process assessment and improvement in this domain. To address this need the Medi SPICE process assessment and improvement model is being developed. Regulatory compliance is both an important and challenging aspect of medical device software development. Particularly as new regulations are being released and existing standards revised due to the attention that software is receiving within the health domain. To comply with these latest developments the Medi SPICE Process Reference Model (PRM) is being developed to conform with ISO/IEC 12207:2008 and the forthcoming release of ISO/IEC 15504-5 (currently under ballot). This paper outlines the development of the Medi SPICE PRM. It also provides details of the schedule for the full release of the Medi SPICE model.

Communications in Computer and Information Science, 2011

Today the amount of software content within medical devices has grown considerably and will conti... more Today the amount of software content within medical devices has grown considerably and will continue to do so as the level of complexity of medical devices continues to increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transition.

Communications in Computer and Information Science, 2012

Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles o... more Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles of agile software development. A software development project is only considered to be truly agile if these values and principles are followed. However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology such as XP difficult to achieve. This paper outlines how we identified the barriers to agile adoption in the medical device software domain through performing a survey. These barriers include: lack of documentation; maintaining traceability; regulatory compliance; lack of up front planning and the process of managing multiple releases. Based on this research recommendations are also made as to how these barriers can be overcome.

Communications in Computer and Information Science, 2011

A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendme... more 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 in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare.

Proceedings of the 2006 international workshop on Global software development for the practitioner - GSD '06, 2006

To support software development globalisation, organisations are increasingly implementing virtua... more To support software development globalisation, organisations are increasingly implementing virtual team strategies. However, these teams have to work within the confines of the factors which distance introduces, thus not always allowing effective coordination, visibility, communication and cooperation to take place. The successful implementation and management of such teams must be done differently to those at single-site locations. To establish what factors significantly affect the implementation of virtual teams, the authors carried out qualitative research in two organisations in Ireland. Results from this research demonstrate that many factors are reality for those involved in global software development. In this paper we present five of these factors and discuss the impact these had on the virtual teams. These five are: use of communication tools, project management, process engineering, technical ability and knowledge transfer and motivational issues. If these are not explicitly addressed by management it can lead to serious problems.

2006 IEEE International Conference on Global Software Engineering (ICGSE'06), 2006

When implementing software development in a global environment, a popular strategy is the establi... more When implementing software development in a global environment, a popular strategy is the establishment of virtual teams. The objective of this paper is to examine the effective project management of this type of team. In the virtual team environment problems arise due to the collaborative nature of software development and the impact distance introduces. Distance specifically impacts coordination, visibility, communication and cooperation within a virtual team. In these circumstances the project management of a virtual team must be carried out in a different manner to that of a team in a single-site location. Results from this research highlighted six specific project management related areas that need to be addressed to facilitate successful virtual team operation. Organizational structure, risk management, infrastructure, process, conflict management and team structure and organization. Additional related areas are the sustained support of senior management and the provision of effective infrastructure.

2008 IEEE International Conference on Global Software Engineering, 2008

Today software development has truly become a globally sourced commodity. This trend has been fac... more Today software development has truly become a globally sourced commodity. This trend has been facilitated by the availability of highly skilled software professionals in low cost locations in Eastern Europe, Latin America and the Far East. Organisations endeavouring to leverage the opportunities this provides and to avail of the benefits of establishing operations close to emerging markets have embraced this strategy in large numbers. Software testing plays a key role in delivering high quality products and is a labour intensive, complex and expensive activity. In the context of Global Software Development (GSD) to date testing has been perceived as a well defined task that is relatively straightforward and lends itself to being outsourced or offshored. This volume considers this specific topic and demonstrates that testing in a GSD environment is not a simple activity. It is prone to be negatively impacted by all the factors associated with distributed software development.This work also provides practical solutions which can be utilised to address these important issues. While the primary focus of this work is software testing it is also the culmination of 10 years research by the author in the area of GSD. During this period he has considered all aspects of the software development life cycle. This experience and knowledge has been incorporated into this volume. It is therefore relevant to note this work is of value to the wider software community not just to those interested in testing. It specifically considers the establishment of virtual teams and their efficient and effective operation. Therefore this book has relevance to all those interested in implementing or improving a GSD strategy. Its particular strengths are that while it is a scholarly work it is industry based and practical

IGI Global eBooks, 2010

Given the requirement for software engineering graduates to operate in Global Software Developmen... more Given the requirement for software engineering graduates to operate in Global Software Development (GSD) environments, educators need to develop teaching methods to enhance and instill GSD knowledge in their students. In this paper, we discuss two projects that provided students with a first-hand learning experience of working within GSD teams. One project was with Siemens Corporate Research, whose focus was to shadow the development of a real-life GSD project. The second project, whose focus was virtual team software testing, was carried out in collaboration with Ball State University. In parallel with these projects we undertook qualitative research during which we analyzed students' own written reflections and face-to-face interviews that focused on their learning experiences in these contexts. We identified three specific forms of learning which had taken place: pedagogical, pragmatic and the acquisition of specific globally distributed knowledge. Our findings confirm that mimicking real work settings has educational benefits for problem-based learning environments.

Shuili Fadian Xuebao, 2013

Since 2010, two significant international regulations regarding medical device developme... more Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III‐high risk to Class I‐ low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve...

On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data... more On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In add...

Software development has become a globally sourced commodity. Software development processes such... more Software development has become a globally sourced commodity. Software development processes such as requirements elicitation, development of components and maintenance tasks are often distributed across sites and countries. This research paper focuses on the distribution of the testing process, which is not a straightforward task. The research presented here has examined the management of virtual teams within a distributed testing environment in two multi-national companies in Ireland. This has elicited many issues over and above the ‘socio-cultural’ issues so often discussed. Some of the difficulties encountered include language differences, use of communication tools, different process maturity levels, tools and standards, technical ability and knowledge management. Apart from the management of the testing process, we are also considering the technical issues involved in the global distribution of testing. A related study is being undertaken with teams of students from Masters cl...

Proceedings of the 7th International Conference on Software Paradigm Trends, 2012

The demand for medical device software continues to grow and there is an associated increase in i... more 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, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software-Software life cycle processes. IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union. This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE. Finally the timeline for the release of the full Medi SPICE model is provided.

Journal of the Brazilian Computer Society, 2010

Globally distributed information systems development has become a key strategy for large sections... more Globally distributed information systems development has become a key strategy for large sections of the software industry. This involves outsourcing projects to third parties or offshoring development to divisions in remote locations. A popular approach when implementing these strategies is the establishment of virtual teams. The justification for embarking on this approach is to endeavor to leverage the potential benefits of labor arbitrage available between geographical locations. When implementing such a strategy organizations must recognize that virtual teams operate differently to collocated teams, therefore, they must be managed differently. These differences arise due to the complex and collaborative nature of information systems development and the impact distance introduces. Geographical, temporal, cultural, and linguistic distance all negatively impact on coordination, cooperation, communication, and visibility in the virtual team setting. In these circumstances, it needs...

ACM Inroads, 2010

Professional software development is normally team based and is recognised as a socio-technical a... more Professional software development is normally team based and is recognised as a socio-technical activity. In recent years, this has been coupled with the increasing popularity of outsourcing and offshoring software development. These are two significant issues, which need to be considered and recognized. As educators, it is important that we prepare our students, at both the undergraduate and postgraduate level to make informed and meaningful contributions to the industry they plan to enter. To facilitate this we need to consider providing modules that outline the benefits and problems associated with globally distributed software development. As research has identified, a key element of any such module is the importance and impact that cultural diversity plays. To facilitate understanding in this area, students can benefit from knowledge of the literature on culture. This can provide essential information which allows them to understand the broader aspects of this important topic. ...

Journal of Software: Evolution and Process, 2013

Non-safety critical software developers have been reaping the benefits of adopting agile practice... more Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as: being contradictory to regulatory requirements; insufficient coverage of risk management activities and the lack of up-front planning. In addition, a comparison is performed between the perceived and actual barriers. Based upon the findings of the literature review and survey, it emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in.

Communications in Computer and Information Science, 2011

Effective verification and validation are central to medical device software development and are ... more Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

Communications in Computer and Information Science, 2011

The benefits of effective verification and validation activities in the medical device domain inc... more 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 there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper highlights three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains.

Communications in Computer and Information Science, 2011

Traceability is central to medical device software development and essential for regulatory appro... more Traceability is central to medical device software development and essential for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This is difficult to achieve due to the lack of specific guidance which the medical device regulations and standards provides. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we briefly outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry.

Communications in Computer and Information Science, 2012

As the importance and complexity of medical device software continues to increase there is growin... more As the importance and complexity of medical device software continues to increase there is growing demand for effective process assessment and improvement in this domain. To address this need the Medi SPICE process assessment and improvement model is being developed. Regulatory compliance is both an important and challenging aspect of medical device software development. Particularly as new regulations are being released and existing standards revised due to the attention that software is receiving within the health domain. To comply with these latest developments the Medi SPICE Process Reference Model (PRM) is being developed to conform with ISO/IEC 12207:2008 and the forthcoming release of ISO/IEC 15504-5 (currently under ballot). This paper outlines the development of the Medi SPICE PRM. It also provides details of the schedule for the full release of the Medi SPICE model.

Communications in Computer and Information Science, 2011

Today the amount of software content within medical devices has grown considerably and will conti... more Today the amount of software content within medical devices has grown considerably and will continue to do so as the level of complexity of medical devices continues to increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transition.

Communications in Computer and Information Science, 2012

Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles o... more Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles of agile software development. A software development project is only considered to be truly agile if these values and principles are followed. However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology such as XP difficult to achieve. This paper outlines how we identified the barriers to agile adoption in the medical device software domain through performing a survey. These barriers include: lack of documentation; maintaining traceability; regulatory compliance; lack of up front planning and the process of managing multiple releases. Based on this research recommendations are also made as to how these barriers can be overcome.

Communications in Computer and Information Science, 2011

A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendme... more 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 in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare.

Proceedings of the 2006 international workshop on Global software development for the practitioner - GSD '06, 2006

To support software development globalisation, organisations are increasingly implementing virtua... more To support software development globalisation, organisations are increasingly implementing virtual team strategies. However, these teams have to work within the confines of the factors which distance introduces, thus not always allowing effective coordination, visibility, communication and cooperation to take place. The successful implementation and management of such teams must be done differently to those at single-site locations. To establish what factors significantly affect the implementation of virtual teams, the authors carried out qualitative research in two organisations in Ireland. Results from this research demonstrate that many factors are reality for those involved in global software development. In this paper we present five of these factors and discuss the impact these had on the virtual teams. These five are: use of communication tools, project management, process engineering, technical ability and knowledge transfer and motivational issues. If these are not explicitly addressed by management it can lead to serious problems.

2006 IEEE International Conference on Global Software Engineering (ICGSE'06), 2006

When implementing software development in a global environment, a popular strategy is the establi... more When implementing software development in a global environment, a popular strategy is the establishment of virtual teams. The objective of this paper is to examine the effective project management of this type of team. In the virtual team environment problems arise due to the collaborative nature of software development and the impact distance introduces. Distance specifically impacts coordination, visibility, communication and cooperation within a virtual team. In these circumstances the project management of a virtual team must be carried out in a different manner to that of a team in a single-site location. Results from this research highlighted six specific project management related areas that need to be addressed to facilitate successful virtual team operation. Organizational structure, risk management, infrastructure, process, conflict management and team structure and organization. Additional related areas are the sustained support of senior management and the provision of effective infrastructure.

2008 IEEE International Conference on Global Software Engineering, 2008

2009 Fourth IEEE International Conference on Global Software Engineering, 2009

In this paper we consider the importance of explicit knowledge management, taking into account th... more In this paper we consider the importance of explicit knowledge management, taking into account the growth of global software engineering and the importance of corporate knowledge. We conclude by suggesting specific areas of research which should be considered important for the implementation of knowledge management within global software engineering environments.