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Formal validation and verification of a medical software critical component
2015
2015 ACM/IEEE International Conference on Formal Methods and Models for Codesign (MEMOCODE)
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The process permits to obtain, through a sequence of refinements, more detailed models that can be formally validated and verified. ...
The process is applied to the validation of the SAM medical software, that is used to measure the patients' stereoacuity in the diagnosis of amblyopia. ...
of Science, Research and Economy, and the Province of Upper Austria in the frame of the COMET center SCCH. ...
doi:10.1109/memcod.2015.7340473
dblp:conf/memocode/ArcainiBGMR15
fatcat:5ji5n62ixrguhlsjv7tseowqhy
Safety and Software Intensive Systems: Challenges Old and New
2007
Future of Software Engineering (FOSE '07)
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There is an increased use of software in safety-critical systems; a trend that is likely to continue in the future. ...
Future of Software Engineering(FOSE'07) 0-7695-2829-5/07 $20.00 ...
Whalen, and Alan Tribble of Rockwell Collins Inc. for their modeling and analysis efforts, and valuable discussions; the support of our work by Ricky Butler, Kelly Hayhurst, and Celeste Bellcastro of the ...
doi:10.1109/fose.2007.18
dblp:conf/icse/Heimdahl07
fatcat:wvqxjym3tngu3pifd7ompbzxke
Healthcare software assurance
2006
AMIA Annual Symposium Proceedings
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Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. ...
These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. ...
Software verification and validation is only one portion of the overall conformity equation. ...
pmid:17238324
pmcid:PMC1839424
fatcat:vwrv4afcn5aptlfqoz5h62zjsa
Improving Verification & Validation in the Medical Device Domain
[chapter]
2011
Communications in Computer and Information Science
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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. ...
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 ...
this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero -the Irish Software ...
doi:10.1007/978-3-642-22206-1_6
fatcat:t4w6f26xb5fonetw6vqjc6flym
Towards the Trustworthy Development of Active Medical Devices: A Hemodialysis Case Study
2016
IEEE Embedded Systems Letters
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2017 pre-print arXiv:1706.06369v1 fatcat:f42idpyqzjhwnhyaiqz6umquue
The use of embedded software is advancing in modern medical devices, so does its capabilities and complexity. ...
We show how informal requirements of hemodialysis machines are modeled and analyzed through a rigorous process and suggest a generalization to a larger class of active medical devices. ...
One of the key recommendations of these standards and guidelines is to adopt formal methods for the development of software-intensive critical systems. ...
doi:10.1109/les.2015.2494459
fatcat:eyz425jhmfhapnhsieoaysqhl4
An Augmented Framework for Formal Analysis of Safety Critical Systems
2017
Journal of Software Engineering and Applications
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A real time case study has been discussed in order to validate the proposed framework. ...
This paper presents an augmented framework for analyzing Safety Critical Systems (SCSs) formally. Due to high risk of failure, development process of SCSs is required more attention. ...
Figure 1 1 of critical systems and formal verification of correctness-by construction as well as 3) validate the required safety properties are met. ...
doi:10.4236/jsea.2017.108039
fatcat:wuf6kn26s5f2bope5o2esf36em
Quality Assurance in Agile Safety-Critical Systems Development
2016
2016 10th International Conference on the Quality of Information and Communications Technology (QUATIC)
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This suggests that for safety critical system development, software systems developed by agile teams will need verification and validation by independent parties. ...
We first discuss the source and nature of complexity in software systems and how a probe -sense -learn approach recommended by the Cynefin Framework is appropriate for designing complex systems and a sense ...
This would lead to some formal communication between the development team and the verification and validation team. ...
doi:10.1109/quatic.2016.016
dblp:conf/quatic/McBrideL16
fatcat:4cj23yfunbafdgkhen23ucsrf4
A Survey on Testing for Cyber Physical System
[chapter]
2015
Lecture Notes in Computer Science
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It asserts a big challenge not only on testing and verifying the correctness of all physical and cyber components of such big systems, but also on integration of these components. ...
This paper develops a categorization of multiple levels of testing required to test CPS and makes a comparison of these levels with the levels of software testing based on the V-model. ...
., present a model-based architecture for validating/verifying the Medical CPS [22] . Their architecture includes components representing models for medical devices and a model for the patient. ...
doi:10.1007/978-3-319-25945-1_12
fatcat:bd5dopncpnaudmvkyefgxxbym4
A Case for Specification Validation
[chapter]
2008
Lecture Notes in Computer Science
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As we are moving from a traditional software development process to a new development paradigm where the process it largely driven by tools and automation, new challenges for verification and validation ...
In this position paper we point out the importance of validation and argue that if we fail to adequately address the validation problem problem the impact of verifying code generation and compilation will ...
Acknowledgements The author wishes to acknowledge the contributions of Dr. Steven P. Miller ...
doi:10.1007/978-3-540-69149-5_42
fatcat:d5b5ndoqv5albmbskyd4ftt64m
Coping with Defective Software in Medical Devices
2006
Computer
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Consequently, it falls to device manufacturers to ensure, to the best of their ability, that software-based medical devices are safe and effective. ...
Meeting this responsibility requires expertise in effective risk management practices, familiarity with software safety, and the adoption of a risk management mind-set. ...
SQA personnel are often responsible for a variety of software verification and validation tasks. 9 Software verification. ...
doi:10.1109/mc.2006.123
fatcat:64ib4ynmpfdybfy5y6puqnmwum
Model-driven development of high-assurance active medical devices
2015
Software quality journal
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2017 pre-print arXiv:1706.06376v1 fatcat:yj4tqbdxo5h4bdm7m7y72c2kiu
This paper presents initial results and lessons learned from an ongoing project focusing on the development of a formal model of a subsystem of a software-controlled safety-critical Active Medical Device ...
scientific and practitioner community of formal methods and software engineering. ...
We are encouraged to proceed with the further development of components of hemodialysis machines. ...
doi:10.1007/s11219-015-9288-0
fatcat:yzylzr64mbaujgzgx4uw2i4evu
Conceptual Design and Resources for a General-Purpose Safety and Performance Verification and Validation Toolkit (V2T) for Life-Critical Wireless Medical Device Networks (WMDN)
2005
2005 IEEE Engineering in Medicine and Biology 27th Annual Conference
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Patient safety risks exist from delayed or lost WMDN alarm and data streams, however, and non-proprietary Verification and Validation (V2) techniques do not exist. ...
V2 of even a homogeneous single vendor, single device WMDNS is very complex for several reasons including: absence of industry standards or regulations, unconstrained mobility of patients and devices, ...
In the case of a complete system installation, a formal, independent validation process is desirable. ...
doi:10.1109/iembs.2005.1616371
pmid:17282140
fatcat:sahc4ci3vrcdrdqi6td5nijvca
Advances in Quantitative Verification for Ubiquitous Computing
[chapter]
2013
Lecture Notes in Computer Science
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• This lecture concerns verification methodology
− emphasises practical, algorithmic techniques and industrially-
relevant tools
10
Software quality assurance
• Software is a critical component ...
engineering
• Verification and validation
− Derive model, or extract from software artefacts
− Verify correctness, validate if fit for purpose
Model
Model Model
Model
Formal
Formal Formal ...
doi:10.1007/978-3-642-39718-9_3
fatcat:emkb7jqcurg37nhkdyeel6icma
Improving Trace Generation and Analysis for Medical Devices
2017
2017 IEEE International Conference on Software Quality, Reliability and Security Companion (QRS-C)
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where only a small part of requirements are considered critical. ...
The MODMED project gathers Blue Ortho, a MD manufacturer, MinMaxMedical, a software provider for MD and the LIG laboratory to propose a solution to modelbased verification of execution traces of MD in ...
doi:10.1109/qrs-c.2017.135
dblp:conf/qrs/BleinCBLGB17
fatcat:rr33oc6doffz7befpxeivtcof4
Linking abstract analysis to concrete design: A hierarchical approach to verify medical CPS safety
2014
2014 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS)
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Formal reasoning about such systems, therefore, necessarily involves the use of multiple modeling formalisms, verification paradigms, and concomitant tools, chosen as appropriate for the level of abstraction ...
Formal reasoning about such systems, therefore, necessarily involves the use of multiple modeling formalisms, verification paradigms, and concomitant tools, chosen as appropriate for the level of abstraction ...
We also thank Miroslav Pajic for helpful discussions on restructuring the model of the closed-loop system. ...
doi:10.1109/iccps.2014.6843718
dblp:conf/iccps/MurugesanSRWHL14
fatcat:hhqzozxfpjfv7bsp6qss42j6gq
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