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Subject = Medical Device Software;
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Displaying Results 1 - 19 of 19 on page 1 of 1
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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 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 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 software risk management capability model for medical device software
(2008)
Burton, John
A software risk management capability model for medical device software
(2008)
Burton, John
Abstract:
The Medical Device industry is currently one of the fastest growing industries in the world and a guarantee of the integrity of medical device software has become increasingly important. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Consequently there is a tremendous onus on medical device manufacturers to demonstrate that sufficient attention is devoted to the area of software risk management throughout the software lifecycle. Failure to do so can lead to a lack of approval from the various regulatory bodies with a consequent surrender of the right to market the device in a particular country. Several different standards, guidance papers and industry guides exist which make it difficult to guarantee conformance in all cases. This diverse set of requirements can make software risk management difficult and this thesis examines the possibility of a unified approach whilst investigating the relevance of the Capability Ma...
http://hdl.handle.net/10344/1204
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Modelling the Haemodialysis Machine with?Circus
(2016)
BUTTERFIELD, ANDREW
Modelling the Haemodialysis Machine with?Circus
(2016)
BUTTERFIELD, ANDREW
http://hdl.handle.net/2262/77373
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Adopting Agile Practices When Developing Software for Use in the Medical Domain
(2014)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Adopting Agile Practices When Developing Software for Use in the Medical Domain
(2014)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Abstract:
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 betw...
https://arrow.dit.ie/scschcomart/32
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An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs
(2013)
McHugh, Martin; Cawley, Oisin; McCaffery, Fergal; Richardson, Ita; Wang, Xiaofeng
An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs
(2013)
McHugh, Martin; Cawley, Oisin; McCaffery, Fergal; Richardson, Ita; Wang, Xiaofeng
Abstract:
Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical devi...
https://arrow.dit.ie/scschcomcon/129
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An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles
(2013)
Mc Hugh, Martin; Cawley, Oisín; Mc Caffery, Fergal; Richardson, Ita; Wang, Xiaofeng
An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles
(2013)
Mc Hugh, Martin; Cawley, Oisín; Mc Caffery, Fergal; Richardson, Ita; Wang, Xiaofeng
Abstract:
Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical devi...
http://hdl.handle.net/10344/3300
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Barriers to using agile software development practices within the medical device industry
(2012)
Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine
Barriers to using agile software development practices within the medical device industry
(2012)
Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine
Abstract:
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 a literature review this research 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 what the actual barriers are to adopting agile practices. In addition a comparison is performed between the perceived and actual barriers and the results are reported.
http://hdl.handle.net/10344/2442
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Barriers to Using Agile Software Development Practices within the Medical Device Industry
(2012)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Barriers to Using Agile Software Development Practices within the Medical Device Industry
(2012)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Abstract:
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 a literature review this research 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 what the actual barriers are to adopting agile practices. In addition a comparison is performed between the perceived and actual barriers and the results are reported.
https://arrow.dit.ie/scschcomcon/124
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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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Development of the Medi SPICE PRM
(2012)
Casey, Valentine; Mc Caffery, Fergal
Development of the Medi SPICE PRM
(2012)
Casey, Valentine; Mc Caffery, Fergal
Abstract:
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.
http://hdl.handle.net/10344/2439
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How Can Software SMEs Become Medical Device
(2011)
McCaffery, Fergal; Casey, Valentine; McHugh, Martin
How Can Software SMEs Become Medical Device
(2011)
McCaffery, Fergal; Casey, Valentine; McHugh, Martin
Abstract:
The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices 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
https://arrow.dit.ie/scschcomcon/120
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Implementation of a lightweight assessment method for medical device software
(2012)
Casey, Valentine; Mc Caffery, Fergal
Implementation of a lightweight assessment method for medical device software
(2012)
Casey, Valentine; Mc Caffery, Fergal
Abstract:
This paper outlines the development and implementation of Medi SPICE-Adept. Medi SPICE-Adept is a lightweight assessment method that has been designed for usage with the Medi SPICE software process assessment and improvement model which is currently being developed for the medical device industry. While the Medi SPICE model is detailed and comprehensive in its approach there is industry demand for a lightweight medical device process assessment and improvement method. To address this requirement Medi SPICE-Adept has been developed. Details on how this has taken place and the procedures for implementing a Medi SPICE-Adept assessment are presented. Information is also provided regarding how a Medi SPICE-Adept assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.
http://hdl.handle.net/10344/2438
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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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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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Med-Trace: traceability assessment method for medical device software development
(2011)
Casey, Valentine; Mc Caffery, Fergal
Med-Trace: traceability assessment method for medical device software development
(2011)
Casey, Valentine; Mc Caffery, Fergal
Abstract:
Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments.
http://hdl.handle.net/10344/1746
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Medi SPICE and the development of a process reference model for inclusion in IEC 62304
(2012)
Casey, Valentine; Mc Caffery, Fergal
Medi SPICE and the development of a process reference model for inclusion in IEC 62304
(2012)
Casey, Valentine; Mc Caffery, Fergal
Abstract:
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 ...
http://hdl.handle.net/10344/2738
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Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304
(2016)
Rust, Peter; Flood, Derek; Mc Caffery, Fergal
Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304
(2016)
Rust, Peter; Flood, Derek; Mc Caffery, Fergal
Abstract:
One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in or-der to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical de...
http://hdl.handle.net/10344/5503
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The development and current status of Medi SPICE
(2013)
Casey, Valentine; Mc Caffery, Fergal
The development and current status of Medi SPICE
(2013)
Casey, Valentine; Mc Caffery, Fergal
Abstract:
There is increasing demand for effective software process assessment and improvement in the medical device industry. This is due to the expanding and complex role that software now plays in the operation and functionality of medical devices. This paper outlines the development and current status of Medi SPICE a software process assessment and improvement model which is being developed to meet the specific requirements of this safety-critical domain. This includes the selection of the most appropriate software process improvement model on which to base Medi SPICE. Its initial development and restructuring to conform to ISO/IEC 15504-5:2012 and ISO/IEC 12207:2008. The structure and content of its process reference model is outlined and an industry based trial assessment of 11 of its processes discussed. Current and future work is considered including the timeframe for the release of a full version of the Medi SPICE model.
http://hdl.handle.net/10344/3849
Displaying Results 1 - 19 of 19 on page 1 of 1
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