You are required to read and agree to the below before accessing a full-text version of an article in the IDE article repository.

The full-text document you are about to access is subject to national and international copyright laws. In most cases (but not necessarily all) the consequence is that personal use is allowed given that the copyright owner is duly acknowledged and respected. All other use (typically) require an explicit permission (often in writing) by the copyright owner.

For the reports in this repository we specifically note that

  • the use of articles under IEEE copyright is governed by the IEEE copyright policy (available at http://www.ieee.org/web/publications/rights/copyrightpolicy.html)
  • the use of articles under ACM copyright is governed by the ACM copyright policy (available at http://www.acm.org/pubs/copyright_policy/)
  • technical reports and other articles issued by M‰lardalen University is free for personal use. For other use, the explicit consent of the authors is required
  • in other cases, please contact the copyright owner for detailed information

By accepting I agree to acknowledge and respect the rights of the copyright owner of the document I am about to access.

If you are in doubt, feel free to contact webmaster@ide.mdh.se

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.mdu.se/publications/5857-}
}