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Formal validation and verification of a medical software critical component

Paolo Arcaini, Silvia Bonfanti, Angelo Gargantini, Atif Mashkoor, Elvinia Riccobene
2015 2015 ACM/IEEE International Conference on Formal Methods and Models for Codesign (MEMOCODE)  
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

Mats P.E. Heimdahl
2007 Future of Software Engineering (FOSE '07)  
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

Jason G Cooper, Keith A Pauley
2006 AMIA Annual Symposium Proceedings  
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]

M. S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman
2011 Communications in Computer and Information Science  
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

Atif Mashkoor, Miklos Biro
2016 IEEE Embedded Systems Letters  
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

Monika Singh, V. K. Jain
2017 Journal of Software Engineering and Applications  
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

Tom McBride, Marion Lepmets
2016 2016 10th International Conference on the Quality of Information and Communications Technology (QUATIC)  
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]

Sara Abbaspour Asadollah, Rafia Inam, Hans Hansson
2015 Lecture Notes in Computer Science  
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]

Mats P. E. Heimdahl
2008 Lecture Notes in Computer Science  
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

S.R. Rakitin
2006 Computer  
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

Atif Mashkoor
2015 Software quality journal  
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)

E.B. Sloane, R. Schrenker
2005 2005 IEEE Engineering in Medicine and Biology 27th Annual Conference  
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]

Marta Kwiatkowska
2013 Lecture Notes in Computer Science  
• 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

Yoann Blein, Arnaud Clere, Fabrice Bertrand, Yves Ledru, Roland Groz, Lydie du Bousquet
2017 2017 IEEE International Conference on Software Quality, Reliability and Security Companion (QRS-C)  
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

Anitha Murugesan, Oleg Sokolsky, Sanjai Rayadurgam, Michael Whalen, Mats Heimdahl, Insup Lee
2014 2014 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS)  
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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