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Author = Lepmets, Marion;
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Displaying Results 1 - 25 of 26 on page 1 of 2
Marked
Mark
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; Cater-Steel, Aileen; Mesquida, Antoni Lluís; O'Connor, Rory V.; M...
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; Cater-Steel, Aileen; Mesquida, Antoni Lluís; O'Connor, Rory V.; McBride, Tom
Abstract:
In an industrial context all process models require a certain amount of tailoring to fit to the business environment of any specific organization in which the model is to be deployed. Process models should therefore be accompanied by tailoring guidelines and approaches to assist with strategic and operational goal alignment that support their use in industry. This paper explores shortcomings of process improvement and the existing process models, suggesting that a more holistic approach should be taken to process improvement in the modern organization. The paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the characteristics of the domain in which they are operate. Knowing their domain helps the organization realize the amount of tailoring and goal alignment necessary to benefit from implementing process model guidance.
http://eprints.dkit.ie/528/
Marked
Mark
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; Cater-Steel, Aileen; Mesquida Calafat, Antoni Lluís; O'Connor, Ro...
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; Cater-Steel, Aileen; Mesquida Calafat, Antoni Lluís; O'Connor, Rory V.; McBride, Tom
Abstract:
In an industrial context all process models require a certain amount of tailoring to fit to the business environment of any specific organization in which the model is to be deployed. Process models should therefore be accompanied by tailoring guidelines and approaches to assist with strategic and operational goal alignment that support their use in industry. This paper explores shortcomings of process improvement and the existing process models, suggesting that a more holistic approach should be taken to process improvement in the modern organization. The paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the characteristics of the domain in which they are operate. Knowing their domain helps the organization realize the amount of tailoring and goal alignment necessary to benefit from implementing process model guidance.
http://hdl.handle.net/10344/4155
Marked
Mark
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; O'Connor, Rory; Cater-Steel, Aileen; Mesquida, Antoni Lluís; McBr...
A Cynefin based approach to process model tailoring and goal alignment
(2014)
Lepmets, Marion; O'Connor, Rory; Cater-Steel, Aileen; Mesquida, Antoni Lluís; McBride, Tom
Abstract:
In an industrial context all process models require a certain amount of tailoring to fit to the business environment of any specific organization in which the model is to be deployed. Process models should therefore be accompanied by tailoring guidelines and approaches to assist with strategic and operational goal alignment that support their use in industry. This paper explores shortcomings of process improvement and the existing process models, suggesting that a more holistic approach should be taken to process improvement in the modern organization. The paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the characteristics of the domain in which they are operate. Knowing their domain helps the organization realize the amount of tailoring and goal alignment necessary to benefit from implementing process model guidance.
http://doras.dcu.ie/20274/
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Mark
A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
Abstract:
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment an...
http://doras.dcu.ie/21090/
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A Lightweight Assessment Method for Medical Device Software Processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
A Lightweight Assessment Method for Medical Device Software Processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
Abstract:
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE® software process assessment model which is currently being developed for the medical device industry. MDevSPICE® is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE® process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing a MDevSPICE-Adept process assessment are presented. Information is also provided regarding how a MDevSPICE® process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment ...
http://eprints.dkit.ie/403/
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Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®
(2016)
McCaffery, Fergal; Lepmets, Marion; Trektere, Kitija; Ozcantop, Ozden; Pikkarainen, Minna
Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®
(2016)
McCaffery, Fergal; Lepmets, Marion; Trektere, Kitija; Ozcantop, Ozden; Pikkarainen, Minna
Abstract:
Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. In order to develop a working medical device system through integrating its sub-systems, the sub-systems’ requirements have to be derived from the overall medical device system requirements. The system requirements are continuously collected, analysed and built from the needs of different stakeholders such as patients, health professionals and other companies offering relevant devices, interfaces and software related to the medical device system under development. Various regulatory requirements have to be achieved for a medical device to be allowed market access. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates the regulatory requirements from the relevant medical device software stan...
http://eprints.dkit.ie/593/
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Assessing against IEC 80001-1
(2013)
MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets,...
Assessing against IEC 80001-1
(2013)
MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets, Marion; Renault, Alain
Abstract:
Medical devices are designed and produced subject to various standards. These standards are recognized by the regulatory authorities within the region in which they are going to be marketed. Traditionally medical devices were placed on a proprietary network; however emergent technology is increasingly seeing medical devices being included on to the general hospital IT network. The incorporation of a medical device into an IT network can introduce risks which can impact the safety, effectiveness & security of the medical device. 80001-1: Application of Risk Management for IT networks incorporating Medical Devices addresses the risk that healthcare can be compromised when a medical device is incorporated into an IT network. In order to address these risks, an assessment of the network against IEC 80001-1 must be performed. To perform an assessment which is compliant with ISO/IEC 15504-2 of an IT network against IEC 80001-1, a process assessment model is required. This paper examin...
http://hdl.handle.net/10344/3127
Marked
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Assessing against IEC 80001-1
(2013)
MacMahon, Silvana Togneri; McCaffery, Fergal; Keenan, Frank; Lepmets, Marion; Eagles, S...
Assessing against IEC 80001-1
(2013)
MacMahon, Silvana Togneri; McCaffery, Fergal; Keenan, Frank; Lepmets, Marion; Eagles, Sherman; Renault, Alain
Abstract:
Medical devices are designed and produced subject to various standards. These standards are recognized by the regulatory authorities within the region in which they are going to be marketed. Traditionally medical devices were placed on a proprietary network; however emergent technology is increasingly seeing medical devices being included on to the general hospital IT network. The incorporation of a medical device into an IT network can introduce risks which can impact the safety, effectiveness & security of the medical device. 80001-1: Application of Risk Management for IT networks incorporating Medical Devices addresses the risk that healthcare can be compromised when a medical device is incorporated into an IT network. In order to address these risks, an assessment of the network against IEC 80001-1 must be performed. To perform an assessment which is compliant with ISO/IEC 15504-2 of an IT network against IEC 80001-1, a process assessment model is required. This paper examin...
http://eprints.dkit.ie/485/
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Mark
Characteristics of a medical device software development framework
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita; Dorling, Alec; Eagle...
Characteristics of a medical device software development framework
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita; Dorling, Alec; Eagles, Sherman
Abstract:
This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software development processes.
http://eprints.dkit.ie/400/
Marked
Mark
Characteristics of a medical device software development framework
(2014)
Clarke, Paul; Lepmets, Marion; Mc Caffery, Fergal; Finnegan, Anita; Dorling, Alec; Eagl...
Characteristics of a medical device software development framework
(2014)
Clarke, Paul; Lepmets, Marion; Mc Caffery, Fergal; Finnegan, Anita; Dorling, Alec; Eagles, Sherman
Abstract:
This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software development processes.
http://hdl.handle.net/10344/4388
Marked
Mark
Characteristics of medical device software development
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
Characteristics of medical device software development
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
Abstract:
This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software development processes.
http://doras.dcu.ie/21091/
Marked
Mark
Development of a process assessment model for assessing medical IT networks against IEC 80001-1
(2012)
MacMahon, Silvana Togneri; McCaffery, Fergal; Keenan, Frank; Lepmets, Marion; Eagles, S...
Development of a process assessment model for assessing medical IT networks against IEC 80001-1
(2012)
MacMahon, Silvana Togneri; McCaffery, Fergal; Keenan, Frank; Lepmets, Marion; Eagles, Sherman; Renault, Alain
Abstract:
Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also exami...
http://eprints.dkit.ie/488/
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Development of a process assessment model for assessing medical IT networks against IEC 80001-1
(2012)
MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets,...
Development of a process assessment model for assessing medical IT networks against IEC 80001-1
(2012)
MacMahon, Silvana Togneri; Mc Caffery, Fergal; Eagles, Sherman; Keenan, Frank; Lepmets, Marion; Renault, Alain
Abstract:
Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also exami...
http://hdl.handle.net/10344/2322
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Development of a Process Assessment Model for Medical Device Software Development
(2014)
Lepmets, Marion; Clarke, Paul; McCaffery, Fergal; Finnegan, Anita; Dorling, Alec
Development of a Process Assessment Model for Medical Device Software Development
(2014)
Lepmets, Marion; Clarke, Paul; McCaffery, Fergal; Finnegan, Anita; Dorling, Alec
Abstract:
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by international standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate resources addressing distinct areas of concern. The result for medical device software developers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regula-tory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integr...
http://eprints.dkit.ie/402/
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Development of a process assessment model for medical device software development
(2014)
Lepmets, Marion; Clarke, Paul; Mc Caffery, Fergal; Dorling, Alec
Development of a process assessment model for medical device software development
(2014)
Lepmets, Marion; Clarke, Paul; Mc Caffery, Fergal; Dorling, Alec
Abstract:
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by internation-al standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate re-sources addressing distinct areas of concern. The result for medical device software develop-ers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regula-tory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the int...
http://hdl.handle.net/10344/4386
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Mark
Development of a process assessment model for medical device software development
(2014)
Lepmets, Marion; Clarke, Paul; McCaffery, Fergal; Finnegan, Anita
Development of a process assessment model for medical device software development
(2014)
Lepmets, Marion; Clarke, Paul; McCaffery, Fergal; Finnegan, Anita
Abstract:
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by international standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate re-sources addressing distinct areas of concern. The result for medical device software developers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regulatory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integr...
http://doras.dcu.ie/21086/
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Harmonizing software development processes with software development settings – a systematic approach
(2013)
Jeners, Simona; Clarke, Paul; O'Connor, Rory V.; Buglione, Luigi; Lepmets, Marion
Harmonizing software development processes with software development settings – a systematic approach
(2013)
Jeners, Simona; Clarke, Paul; O'Connor, Rory V.; Buglione, Luigi; Lepmets, Marion
Abstract:
The software process landscape is rich in complexity and many alternative software development approaches have emerged over the past 40 years. However, no single software development approach is universally implemented and it seems likely that no single approach can be universally useful. One of the primary reasons that no single approach is universally useful is that no two software development settings are identical. We have assembled a team of recognized academics, who together with industrial collaborators, plan to map the complex world of software processes with the context of software development projects. The results of our initial mapping efforts, reported in this paper, demonstrate that although there are challenges in an undertaking such as this, the outcomes are potentially of considerable value to both software researchers and practitioners.
http://hdl.handle.net/10344/3226
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Harmonizing software development processes with software development settings – A systematic approach
(2013)
Jeners, Simona; Clarke, Paul; O'Connor, Rory; Buglione, Luigi; Lepmets, Marion
Harmonizing software development processes with software development settings – A systematic approach
(2013)
Jeners, Simona; Clarke, Paul; O'Connor, Rory; Buglione, Luigi; Lepmets, Marion
Abstract:
The software process landscape is rich in complexity and many alternative software development approaches have emerged over the past 40 years. However, no single software development approach is universally implemented and it seems likely that no single approach can be universally useful. One of the primary reasons that no single approach is universally useful is that no two software development settings are identical. We have assembled a team of recognized academics, who together with industrial collaborators, plan to map the complex world of software processes with the context of software development projects. The results of our initial mapping efforts, reported in this paper, demonstrate that although there are challenges in an undertaking such as this, the outcomes are potentially of considerable value to both software researchers and practitioners.
http://doras.dcu.ie/18634/
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Harnessing software development contexts to inform software process selection decisions
(2013)
Jeners, Simona; O'Connor, Rory V.; Clake, Paul; Lichter, Horst; Lepmets, Marion; B...
Harnessing software development contexts to inform software process selection decisions
(2013)
Jeners, Simona; O'Connor, Rory V.; Clake, Paul; Lichter, Horst; Lepmets, Marion; Buglione, Luigi
Abstract:
Software development is a complex process for which numerous approaches have been suggested. However, no single approach to software development has been met with universal acceptance, which is not surprising, as there are many different software development concerns. In addition, there are a multitude of other contextual factors that influence the choice of software development process and process management decisions. The authors believe it is important to develop a robust mechanism for relating software process decisions and software development contexts. Such an approach supports industry practitioners in their efforts to implement the software development processes vital for a particular set of contextual factors. In this paper, the authors outline a new tool-based framework for relating the complexity of software settings with the various aspects of software processes. This framework can extract the key software process concepts from process repositories, for example, from CMM...
http://hdl.handle.net/10344/3669
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Harnessing software development contexts to inform software process selection decisions
(2013)
Jeners, Simona; O'Connor, Rory; Clarke, Paul; Lichter, H.; Lepmets, Marion; Buglio...
Harnessing software development contexts to inform software process selection decisions
(2013)
Jeners, Simona; O'Connor, Rory; Clarke, Paul; Lichter, H.; Lepmets, Marion; Buglione, Luigi
Abstract:
Software development is a complex process for which numerous approaches have been suggested. However, no single approach to software development has been met with universal acceptance, which is not surprising, as there are many different software development concerns. In addition, there are a multitude of other contextual factors that influence the choice of software development process and process management decisions. The authors believe it is important to develop a robust mechanism for relating software process decisions and software development contexts. Such an approach supports industry practitioners in their efforts to implement the software development processes vital for a particular set of contextual factors. In this paper, the authors outline a new tool-based framework for relating the complexity of software settings with the various aspects of software processes. This framework can extract the key software process concepts from process repositories, for example, from CMM...
http://doras.dcu.ie/19730/
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MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
Abstract:
Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.
http://doras.dcu.ie/21089/
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Medical device software as a subsystem of an overall medical device
(2015)
McCaffery, Fergal; Lepmets, Marion; Clarke, Paul
Medical device software as a subsystem of an overall medical device
(2015)
McCaffery, Fergal; Lepmets, Marion; Clarke, Paul
Abstract:
Embedded software is a sub-system that needs to be integrated with the electrical and mechanical subsystems for a functional medical device to be developed and marketed. In order to be able to develop a medical device system through integrating its sub-systems, the complete system requirements should be known at the start of the project and managed throughout development. Software requirements are then derived from the systems requirements. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates processes from various medical device software standards as well as generic software development standards. This paper describes how the MDevSPICE® framework has been designed so as to enable medical device software developers to produce software that will be safe and easily integrated with other sub-systems of the overall medical device. We also describe the lessons learned from piloting MDevSPICE® in the medical device industry...
http://doras.dcu.ie/21085/
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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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Piloting MDevSPICE: the medical device software process assessment framework
(2015)
Lepmets, Marion; McCaffery, Fergal; Clarke, Paul
Piloting MDevSPICE: the medical device software process assessment framework
(2015)
Lepmets, Marion; McCaffery, Fergal; Clarke, Paul
Abstract:
Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards’ requirements enabling consistent and thorough assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. The MDevSPICE® framework consis...
http://doras.dcu.ie/21087/
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Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability
(2015)
Clarke, Paul; Lepmets, Marion; Dorling, Alec; McCaffery, Fergal
Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability
(2015)
Clarke, Paul; Lepmets, Marion; Dorling, Alec; McCaffery, Fergal
Abstract:
One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.
http://doras.dcu.ie/21088/
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