loading
Papers Papers/2022 Papers Papers/2022

Research.Publish.Connect.

Paper

Paper Unlock

Authors: Hamsini Ketheswarasarma Rajaram 1 ; John Loane 1 ; Silvana Togneri MacMahon 2 and Fergal Mc Caffery 1

Affiliations: 1 Regulated Software Research Centre, Dundalk Institute of Technology, Dundalk, Ireland ; 2 School of Computing, Dublin City University, Dublin, Ireland

Keyword(s): The US FDA, Taxonomy, SW91, ISO/IEC/IEEE 29119, IEC 62304, Framework, Expert Review, Software Testing, Recalls.

Abstract: This paper details the expert review of a framework developed to implement a novel testing approach called taxonomy-based testing (TBT) for the medical device software domain. This framework proposes three approaches to implement TBT and has been validated by experts from the software testing industry and the medical device software domain. This paper details the results from the expert review. The expert review focused on validating the three approaches to TBT, the benefits of TBT to medical device software development, the accuracy of mappings of testing techniques from ISTQB and ISO/IEC/IEEE 29119-4:2015 to defects from a defect taxonomy, the integration of TBT into the standard test processes, ISTQB and ISO/IEC/IEEE 29119-2:2013 and the structure of the framework. The contribution of this paper is to reveal that (i) the framework is implementable in medical device software organisations that follow the IEC 62304:2006+A1:2015 software development process or that use standard test processes, (ii) using a defect taxonomy could standardise the application of experience-based approaches to software testing and (iii) considering potential defects before writing test cases could identify additional defects for test cases. (More)

CC BY-NC-ND 4.0

Sign In Guest: Register as new SciTePress user now for free.

Sign In SciTePress user: please login.

PDF ImageMy Papers

You are not signed in, therefore limits apply to your IP address 3.235.130.73

In the current month:
Recent papers: 100 available of 100 total
2+ years older papers: 200 available of 200 total

Paper citation in several formats:
Rajaram, H.; Loane, J.; MacMahon, S. and Caffery, F. (2021). Expert Review of Taxonomy based Testing: A Testing Framework for Medical Device Software. In Proceedings of the 16th International Conference on Evaluation of Novel Approaches to Software Engineering - ENASE; ISBN 978-989-758-508-1; ISSN 2184-4895, SciTePress, pages 331-339. DOI: 10.5220/0010458503310339

@conference{enase21,
author={Hamsini Ketheswarasarma Rajaram. and John Loane. and Silvana Togneri MacMahon. and Fergal Mc Caffery.},
title={Expert Review of Taxonomy based Testing: A Testing Framework for Medical Device Software},
booktitle={Proceedings of the 16th International Conference on Evaluation of Novel Approaches to Software Engineering - ENASE},
year={2021},
pages={331-339},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010458503310339},
isbn={978-989-758-508-1},
issn={2184-4895},
}

TY - CONF

JO - Proceedings of the 16th International Conference on Evaluation of Novel Approaches to Software Engineering - ENASE
TI - Expert Review of Taxonomy based Testing: A Testing Framework for Medical Device Software
SN - 978-989-758-508-1
IS - 2184-4895
AU - Rajaram, H.
AU - Loane, J.
AU - MacMahon, S.
AU - Caffery, F.
PY - 2021
SP - 331
EP - 339
DO - 10.5220/0010458503310339
PB - SciTePress