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A Software Process Improvement Roadmap for IEC 62304: An Expert Review [chapter]

Peter Rust, Derek Flood, Gilbert Regan, Fergal McCaffery
2018 Communications in Computer and Information Science  
A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard.  ...  IEC 62304 Medical device software -Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard.  ...  support of the Science Foundation Ireland grant 13/RC/2094 and co-funded under the European Regional Development Fund through the Southern & Eastern Regional Operational Programme to Lero -the Irish Software  ... 
doi:10.1007/978-3-319-97925-0_50 fatcat:synstrmnt5ayzheh74mexu4ddm

A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with IEC 62366 [chapter]

Derek Flood, Fergal Mc Caffery, Valentine Casey, Gilbert Regan
2013 Communications in Computer and Information Science  
In this paper we introduce the concept of the software process improvement roadmaps for the implementation of standards and detail a methodology for developing these roadmaps.  ...  As part of these initiatives organisations undergo an assessment and then embark on a software process improvement program to improve their existing processes to meet a desired target.  ...  Stokes Lectureship Programme, grant number 07/SK/I1299, the SFI Principal Investigator Programme, grant number 08/IN.1/I2030 (the funding of this project was awarded by Science Foundation Ireland under a  ... 
doi:10.1007/978-3-642-39179-8_3 fatcat:tfrtpfrpdbgb5nz4epfkeokuri

Creation of an IEC 62304 compliant software development plan

Peter Rust, Derek Flood, Fergal McCaffery
2016 Journal of Software: Evolution and Process  
One such standard IEC 62304, Medical device software -Software life-cycle processes, defines the processes that are required in order to develop safe software.  ...  Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain.  ...  In previous work, an IEC 62304 implementation roadmap has been developed [8] and is currently being prepared for validation by industry experts.  ... 
doi:10.1002/smr.1826 fatcat:vtmmgjfnnnenfnuyn66byzoqhy

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME's Developing Medical Device Software in the Implementation of IEC 62304 [chapter]

Peter Rust, Derek Flood, Fergal McCaffery
2016 Communications in Computer and Information Science  
IEC 62304, Medical device software -software life cycle processes, is a standard that defines the processes that are required to be executed in order 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.  ...  A roadmap has also been developed for traceability in the medical device domain and now with the development of an IEC 62304 roadmap, the suite is nearing completion. 2.2 Process used to develop the  ... 
doi:10.1007/978-3-319-38980-6_4 fatcat:hla6rbynmbgufg7rmjtvrpambi

Fundamentos do IEC 62304 com um Modelo Ágil de Desenvolvimento de Software [chapter]

Johnny Marques, Lilian Barros, Sarasuaty Yelisetty, Talita Slavov
2021 Minicursos do SBCAS 2021  
Conclusion: This book chapter provided a lecture with fundamentals of IEC 62304, including an Agile Software Development Model.  ...  Objective: This chapter aims to present the fundamentals of IEC 62304 with an Agile Software Development Model. Justification and motivation: In 2021, IEC 62304 completes 15 years.  ...  Hierarchy of the MDS life cycle The Medical Device Software manufacturer must apply a risk management pro- IEC 62304 had an amendment introduced in 2015 and is under review for improvement.  ... 
doi:10.5753/sbc.7770.2.3 fatcat:5rlapwpp7rbwlbza7birl5gove

The Development and Validation of a Roadmap for Traceability [chapter]

Gilbert Regan, Derek Flood, Fergal Mc Caffery
2015 Communications in Computer and Information Science  
Section 4 details the structure of the developed roadmap while Section 5 presents the findings of an expert evaluation of the roadmap and a discussion of those findings, while Section 6 concludes the paper  ...  A project suffers from excessive overhead without commensurate quality improvement. 2.  ...  to IEC 62304; Expert 8 has experience in industry software development, open source software development and roadmap development.  ... 
doi:10.1007/978-3-319-19860-6_5 fatcat:63tef7zbrrd2nhp6ztirhjeffy

A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps [chapter]

Derek Flood, Fergal Mc Caffery, Gilbert Regan, Val Casey
2014 Communications in Computer and Information Science  
In this work we present a concept for a Software Process Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents.  ...  This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medical device manufacturers.  ...  Stokes Lectureship Programme, grant number 07/SK/I1299, the SFI Principal Investigator Programme, grant number 08/IN.1/I2030 (the funding of this project was awarded by Science Foundation Ireland under a  ... 
doi:10.1007/978-3-662-43896-1_4 fatcat:jrullxxg4vcwzmaojhrkjanyv4

Mobile medical app development with a focus on traceability

Kitija Trektere, Gilbert Regan, Fergal Mc Caffery, Derek Flood, Marion Lepmets, Grainne Barry
2017 Journal of Software: Evolution and Process  
Furthermore, we describe how MDevSPICE ® together with an agile software development approach can be tailored to support a mobile medical applications development framework.  ...  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  ...  Acknowledgments This research is supported by the Science Foundation Ireland Research Centres Programme, through Lero -the Irish Software Research Centre (http://www.lero.ie)  ... 
doi:10.1002/smr.1861 fatcat:dqanno6vcvgknoqz77oy2sy72m

A roadmap to ISO 14971 implementation

Derek Flood, Fergal McCaffery, Valentine Casey, Ruth McKeever, Peter Rust
2015 Journal of Software: Evolution and Process  
The implementation of a risk management process for the medical device domain can be a costly and time consuming process, however this can be alleviated through the use of a software process improvement  ...  The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard.  ...  Stokes Lectureship Programme, grant number 07/SK/I1299, the SFI Principal Investigator Programme, grant number 08/IN.1/I2030 (the funding of this project was awarded by Science Foundation Ireland under a  ... 
doi:10.1002/smr.1711 fatcat:ouvvdzvbkbfx3kmkdr36e4ba5q

Improving Safety in Medical Devices from Concept to Retirement [chapter]

Martin McHugh, Fergal McCaffery, Silvana Togneri MacMahon, Anita Finnegan
2013 Handbook of Medical and Healthcare Technologies  
One advantage of following IEC 62304 is that medical device software development organizations following IEC 62304 are not obliged to describe their processes in detail when seeking regulatory approval  ...  IEC SC62A JWG3) and industry experts.  ...  To overcome this, medical device software organizations are recommended to follow the latest state of the art development processes and standards such as IEC 62304; however, IEC 62304 has not been updated  ... 
doi:10.1007/978-1-4614-8495-0_21 fatcat:wmcyzec63bf67ekreddt6xh3mu

Safety Critical Software Development – Extending Quality Management System Practices to Achieve Compliance with Regulatory Requirements [chapter]

Andrzej Beniamin Bujok, Silvana Togneri MacMahon, Fergal McCaffery, Dick Whelan, Bernard Mulcahy, William J. Rickard
2016 Communications in Computer and Information Science  
A literature review was conducted which examines the relevant Quality management system, Risk Management and Software development standards across the safety critical domains.  ...  The complexity involved in the development of software for these domains can bring challenges concerned with safety and security.  ...  Various fields related to medical device software development were investigated, such as Software process improvement and Roadmaps [26] , Integration agile with a Medical device software development  ... 
doi:10.1007/978-3-319-38980-6_2 fatcat:4jgifitbwbdwjbtyyelzbzeqaa

Research findings from an industrial trial of a traceability assessment and implementation framework

Gilbert Regan, Derek Flood, Fergal Mc Caffery
2016 Proceedings of the International Workshop on Software and Systems Process - ICSSP '16  
Our findings show that implementation of the framework within two organizations improved their traceability process and that both organizations found the framework to be both useful and usable.  ...  This is problematic as traceability plays an important role in the development of safe and reliable software.  ...  This order of implementation arose as a result of the roadmap validation through expert review.  ... 
doi:10.1145/2904354.2904365 dblp:conf/ispw/ReganFM16 fatcat:guakiixfhngifg4rei3b273z7e

Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

Stephen Gilbert, Matthew Fenech, Martin Hirsch, Shubhanan Upadhyay, Andrea Biasiucci, Johannes Starlinger
2021 Journal of Medical Internet Research  
much-needed paradigm shift, and strive for a balanced approach to enabling rapid improvements in health care through AI innovation while simultaneously ensuring patient safety.  ...  However, health care ML models are currently essentially regulated under provisions that were developed for an earlier age of slowly updated medical devices—requiring major documentation reshape and revalidation  ...  More specifically, the group recommends that the international standard describing software life cycle processes (IEC 62304) [17] should be updated, requiring manufacturers to define an ACP for adaptive  ... 
doi:10.2196/30545 pmid:34697010 pmcid:PMC8579211 fatcat:tnypt3u6pzcq7ajkjpmvnzxhfi

A Limb Hypothermia Wearable for Chemotherapy-Induced Peripheral Neuropathy: A Mixed-Methods Approach in Medical Product Development

Jonathan Binder, Ertu Unver, Jane Clayton, Patrick Burke, Richard Paxman, Raghav Sundar, Aishwarya Bandla
2020 Frontiers in Digital Health  
design & development process.  ...  User-based approaches facilitated stakeholder-feedback through expert focus groups, informing further design & development and projecting the design into the next stage, Beta prototyping, for use in  ...  PB, RP, and RS revised the manuscript critically and for important intellectual content. All authors read and approved the final manuscript.  ... 
doi:10.3389/fdgth.2020.573234 pmid:34713046 pmcid:PMC8521967 fatcat:lprwrqaz2nerhiocey5ozvl2qu

OnRAMP for Regulating Artificial Intelligence in Medical Products

David C. Higgins
2021 Advanced Intelligent Systems  
a certification process.  ...  This Perspective proposes best practice guidelines for development compatible with the production of a regulatory package which, regardless of the formal regulatory path, will form a core component of  ...  Richard Tomsett, Richard Baxter, Oliver Rieger, and Jonas Seiler for their help in reviewing early drafts of this manuscript.  ... 
doi:10.1002/aisy.202100042 fatcat:qcipgz3kgzbarl6p5pcvlwjoji
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