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Process Compliance Re-Certification Efficiency Enabled by EPF-C ° BVR-T

Fulltext:


Publication Type:

Conference/Workshop Paper

Venue:

13th International Conference on the Quality of Information and Communications Technology- Track: Process Modeling, Improvement and Assessment

DOI:

10.1007/978-3-030-58793-2_17


Abstract

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.

Bibtex

@inproceedings{Gallina5857,
author = {Barbara Gallina and Aleksand{\"e}r Pulla and Antonela Bregu and Julieth Patricia Castellanos Ardila},
title = {Process Compliance Re-Certification Efficiency Enabled by EPF-C ° BVR-T},
month = {September},
year = {2020},
booktitle = {13th International Conference on the Quality of Information and Communications Technology- Track: Process Modeling, Improvement and Assessment},
url = {http://www.es.mdh.se/publications/5857-}
}