Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices

Abstract: The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. The first de-facto platform for re-certification is delivered by AMASS project. This thesis is expected to fill the specific gap: evaluate the compliance re-certification efficiency of the platform in the medical domain during the re-certification effort required as a consequence of a change in the normative space. Due to the lack of demonstrations in this safety-critical domain, the standard for medical devices, ISO 14971 with its versions and the Notified Bodies Recommendation Group (NBRG) Consensus paper are considered. There are several differences among them, in terms of the normative part and the fact whether they are international or only applicable in Europe. The evaluation will be conducted on acase study and the research has followed best practicing in case study design/execution. The focus is on two changes. The first change in the normative space is represented by the introduction of the EU directives (EU Medical Device Directives (MDDs): 90/385/EEC, 93/42/EEC, and 98/79/EC.) in relation to ISO 14971:2007, which required the introduction of ISO 14971:2012 (which applies only to manufacturers placing devices on the market in Europe). The second change is represented by the introduction of ISO 14971:2019, an international standard. Through the tool-chain (EPF Composer-BVR Tool), the families of standards and processes are modeled. The reuse of components is assessed through the application of selected metrics creating the measurement framework.The aim is to increase evidence according to the usefulness of the tool-chain in other domains. This master thesis will contribute with a case study evaluation of the tool-chain (a subset of the platform), considering cross-jurisdictional challenges. This work could represent the starting point for an evaluation where not only reference-processes are considered, but also the processes actually modelled in industrial settings.