Process Compliance Re-Certification Efficiency Enabled by EPF-C \(\circ \) BVR-T: A Case Study
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 \(\circ \) BVR-T, obtained by the integration of EP
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. 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 efficiencyrelated criteria, we evaluate the recertification efficiency enabled by the change management strategy implemented in the tool-chain. Keywords: (Re)certification
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· Process compliance · ISO 14971
Introduction
With today’s ever increasing demands on process (re)certification, enabling (re)certification efficiency is paramount. The AMASS project [18] has delivered the first de-facto platform for (re)certification [17]. This platform includes a toolchain, called EPF-C ◦ BVR-T in this paper, obtained by integrating EPF Composer (EPF-C) and BVR Tool (BVR-T). EPF-C ◦ BVR-T supports process engineers in the engineering and compliance demonstration activities as well as variability and change management. The compliance recertification efficiency of the tool-chain has been illustrated and partially demonstrated in the space domain taking into consideration recertification needs in case of different types of changes, e.g. criticality level [4], concern (safety/security [6]). However, the Partially funded by EU and VINNOVA via the ECSEL JU under grant agreement No. 692474, AMASS project. c Springer Nature Switzerland AG 2020 M. Shepperd et al. (Eds.): QUATIC 2020, CCIS 1266, pp. 211–219, 2020. https://doi.org/10.1007/978-3-030-58793-2_17
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tool-chain has not been evaluated in the medical domain and never for handling the recertification effort needed in case of products crossing jurisdictions and thus having to comply with different versions of the same standard. As known, medical devices are governed by a broad range of national and international regulations and medical equipment certification standards. These regulatory requirements are complex and vary between regions, which can make it challenging to gain medical approval for products within a specific targeted market. An evident example is represented by the requirements, included within ISO 14971:2007 and its evolution (EN ISO 14971:2012, ISO 14971:2019), regarding the process for risk analysis and evaluation. When published, ISO 14971:2007 was internationally endorsed. Then, EN ISO 14971:2012 was released for the European market only as a version harmonised with a set of EU directives (90/385/EEC [3], 93/42/EEC [2], and 98/79/EC [16]). As a consequen
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