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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.  ...  Future work will focus on the integration of practices which need to be implemented by companies developing safety critical software.  ...  Fig. 1 . 1 Integrated requirements of Quality management system, Software development and Risk management standards implemented as required practices in safety critical domains.  ... 
doi:10.1007/978-3-319-38980-6_2 fatcat:4jgifitbwbdwjbtyyelzbzeqaa

Development of a Normative Package for Safety-Critical Software Using Formal Regulatory Requirements [chapter]

Sergiy A. Vilkomir, Aditya K. Ghose
2004 Lecture Notes in Computer Science  
The important tasks in requirement engineering are resolving requirements inconsistencies between regulators and developers of safety-critical computer systems, and the validation of regulatory requirements  ...  We propose the use of formal regulatory requirements as a basis for development of software assessment methods.  ...  In our case -safety assessment of software for safety-critical computer systems.  ... 
doi:10.1007/978-3-540-24659-6_38 fatcat:v3yy4ini5rarrkqtltxwabm7k4

How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE®? [chapter]

Özden Özcan-Top, Fergal McCaffery
2017 Communications in Computer and Information Science  
Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time to market, improve customer and employee satisfaction and ensure both  ...  We investigated to what extend the regulatory requirements defined in MDevSPICE ® are met with implementation of the Scrum method and what additional processes and practices have to be performed to ensure  ...  This research is supported by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund through Lero -the Irish Software Research Centre (http  ... 
doi:10.1007/978-3-319-67383-7_19 fatcat:jlnoot6nffgpppaqhdjtkd4kda

Towards Safer Medical Device Software Systems: Industry-Wide Learning from Failures and the Use of Safety-Cases to Support Process Compliance

Marion Lepmets, Tom McBride, Fergal McCaffery
2016 2016 10th International Conference on the Quality of Information and Communications Technology (QUATIC)  
Software safety is checked today in regulatory audits, which verify software development process compliance to regulatory requirements.  ...  Checking process compliance to required standards ensures the quality of the processes by which software is developed but does not necessarily indicate the quality of the resultant software.  ...  They fail to incorporate the quality assurance thinking that is central to safety critical systems development.  ... 
doi:10.1109/quatic.2016.049 dblp:conf/quatic/LepmetsMM16 fatcat:lzptozaptvdkbhwxrnsfbuzcyu

Piloting MDevSPICE: the medical device software process assessment framework

Marion Lepmets, Fergal Mc Caffery, Paul Clarke
2015 Proceedings of the 2015 International Conference on Software and System Process - ICSSP 2015  
quality and more robust software; (3) a software development company seeking to achieve regulatory compliance against IEC 62304 so that they can become medical device software suppliers; and (4) a large  ...  ensure that they are incorporating best practices within their software development processes to not only achieve regulatory compliance but also reduce the likelihood of recalls through developing better  ... 
doi:10.1145/2785592.2785598 dblp:conf/ispw/LepmetsMC15 fatcat:6l6deynr55b6flc7uzuihipypy

Verification & Validation in Medi SPICE [chapter]

M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman
2011 Communications in Computer and Information Science  
Effective verification and validation are central to medical device software development and are essential for regulatory approval.  ...  This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.  ...  Therefore, existing software process reference models need to be adapted and extended to meet the specific requirements of medical device software development which is safety-critical in nature.  ... 
doi:10.1007/978-3-642-21233-8_7 fatcat:kvty2dwapvbzhg25p7fycbk3sa

Introducing Traceability in GitHub for Medical Software Development [article]

Vlad Stirbu, Tommi Mikkonen
2021 arXiv   pre-print
Assuring traceability from requirements to implementation is a key element when developing safety critical software systems.  ...  regulatory purposes in the process.  ...  Acknowledgements The authors would like to thank Business Finland and the members of the AHMED (Agile and Holistic MEdical software Development) consortium for their contribution in preparing this paper  ... 
arXiv:2110.13034v1 fatcat:r35b3oo4cnd7rc7ppfran53fmy

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

M. McHugh, F. McCaffery, V. Casey
2012 IET Software  
latest regulatory requirements.  ...  to produce regulatory compliant medical device software.  ...  Safety critical software systems can be divided into items running a different software element each with its own safety classification.  ... 
doi:10.1049/iet-sen.2011.0198 fatcat:oiqevkguivbxxgw32qxamlr4pa

Certifiably safe software-dependent systems: challenges and directions

John Hatcliff, Alan Wassyng, Tim Kelly, Cyrille Comar, Paul Jones
2014 Proceedings of the on Future of Software Engineering - FOSE 2014  
This paper considers the future of software engineering as needed to support development and certification of safety-critical softwaredependent systems.  ...  Mere compliance with existing standards, techniques, and regulations cannot guarantee the safety properties of these systems. The gap between practice and capability is increasing rapidly.  ...  ACKNOWLEDGEMENTS The authors wish to thank Tom Maibaum (McMaster Centre for Software Certification, McMaster University) for his comments on earlier versions of this paper.  ... 
doi:10.1145/2593882.2593895 dblp:conf/icse/HatcliffWKCJ14 fatcat:cclqub6ianezlgyt4o7e4wp4ja

A Lightweight Assessment Method for Medical Device Software Processes [chapter]

Fergal McCaffery, Paul Clarke, Marion Lepmets
2014 Communications in Computer and Information Science  
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.  ...  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.  ...  and were not developed to provide coverage of all the necessary areas required to achieve domain specific requirements such as medical device regulatory compliance [25] .  ... 
doi:10.1007/978-3-319-13036-1_13 fatcat:wn3uawu3erd57giwiccwulggea

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Gilbert Regan, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
2013 Computer Standards & Interfaces  
Developing safety critical software is a complex process.  ...  Risk management has an important role in medical device software development as it is important to ensure that safe software is developed.  ...  An effective traceability process is a crucial requirement to achieving regulatory compliance.  ... 
doi:10.1016/j.csi.2013.07.012 fatcat:hpujdnizvng7bclwqm6c4vqoou

A Quality Assurance Model for Airborne Safety-Critical Software

Nadia Bhuiyan, Habib A. ElSabbagh
2014 Journal of Software Engineering and Applications  
We propose a lifecycle specially modeled for the development of safety-critical software in compliance with the DO-178B standard and a software quality assurance (SQA) model based on a set of four acceptance  ...  Safety-critical software is widely applied in diverse areas, ranging from medical equipment to airborne systems.  ...  Is safety-critical software quality controllable and manageable like any other software? How should safety-critical software quality be built and managed?  ... 
doi:10.4236/jsea.2014.73018 fatcat:klhga5kpe5bmbkcqhqqowswkne

Scaling agile methods to regulated environments: An industry case study

Brian Fitzgerald, Klaas-Jan Stol, Ryan O'Sullivan, Donal O'Brien
2013 2013 35th International Conference on Software Engineering (ICSE)  
Agile methods were seen initially as best suited to small, co-located teams developing non-critical systems.  ...  However, the applicability of agile methods for developing safety-critical systems in regulated environments has not yet been demonstrated unequivocally, and very little rigorous research exists in this  ...  ACKNOWLEDGMENTS The authors wish to thank Joanne O'Driscoll for her input to this paper. This work was supported, in part, by Science Foundation Ireland grant 10/CE/I1855 to Lero.  ... 
doi:10.1109/icse.2013.6606635 dblp:conf/icse/FitzgeraldSOO13 fatcat:zcb4xeegkrbr3catjpb7krphce

A hybrid assessment approach for medical device software development companies

Özden Özcan-Top, Fergal McCaffery
2017 Journal of Software: Evolution and Process  
Medical device software development organisations are bound by regulatory requirements and constraints to ensure that developed medical devices will not harm patients.  ...  Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a medical device software process assessment framework called MDevSPICE  ...  To assist software development organisations in the medical device domain and to achieve regulatory compliance, the authors have previously developed an integrated framework of medical device software  ... 
doi:10.1002/smr.1929 fatcat:wmr67wkjvvgchbwlev327erhui

Technical note:Beyond Good Laboratory Practice

Dick Le Vitt
1992 Journal of Automatic Chemistry  
An independent Quality Assurance Unit (QAU) must review each study for compliance with GLP requirements.  ...  Scope of GLP In regulatory language, good laboratory practice is a management system to ensure that experimental studies produce authentic results.  ... 
doi:10.1155/s1463924692000361 pmid:18924953 pmcid:PMC2547980 fatcat:nspbexrlg5b2hfzjauk4dxp23i
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