Process Compliance Re-Certification Efficiency Enabled by EPF-C ° BVR-T: A Case Study
2020 (English)In: Quality of Information and Communications Technology, QUATIC 2020, Springer, 2020, p. 211-219Conference paper, Published paper (Refereed)
Abstract [en]
With today’s ever increasing demands on process (re)certification, enabling (re)certification efficiency is paramount. Within the EU AMASS project, we delivered a tool-chain, called, in this paper, EPF-C ° BVR-T, obtained by the integration of EPF Composer (EPF-C) and BVR Tool (BVR-T). This tool-chain supports process engineers in the engineering and compliance demonstration activities as well as variability and change management. The compliance recertification efficiency enabled by the tool-chain has not been evaluated for changes triggered by different jurisdictions, which impose the release of new standards. Thus, to fill this gap, in this case study paper, we focus on the medical domain, precisely on the evolution of the ISO 14971 process for risk analysis and evaluation for medical devices. Based on a set of efficiency-related criteria, we evaluate the recertification efficiency enabled by the change management strategy implemented in the tool-chain.
Place, publisher, year, edition, pages
Springer, 2020. p. 211-219
Keywords [en]
(Re)certification, Process compliance, ISO 14971
National Category
Engineering and Technology Computer Systems
Identifiers
URN: urn:nbn:se:mdh:diva-49975DOI: 10.1007/978-3-030-58793-2_17Scopus ID: 2-s2.0-85091176979ISBN: 978-3-030-58792-5 (print)ISBN: 978-3-030-58793-2 (electronic)OAI: oai:DiVA.org:mdh-49975DiVA, id: diva2:1471767
Conference
13th International Conference on the Quality of Information and Communications Technology- Track: Process Modeling, Improvement and Assessment QUATIC-2020, 09 Sep 2020, Faro, Portugal
Projects
AMASS - Architecture-driven, Multi-concern and Seamless Assurance and Certification of Cyber-Physical Systems2020-09-292020-09-292021-06-24Bibliographically approved