Medical Device Software: From Requirements to Certification

Abstract

The role of software in healthcare is getting more and more pervasive. Nevertheless, manufacturers sometimes forget that these software are medical devices and must be certified according to the EU Medical Device Regulation 2017/745. In this work we propose a pipeline for developing a Medical Device Software (MDS) compliant with the regulations and certifiable. The pipeline includes the phase of requirements elicitation, risk assessment and analysis of effectiveness as key elements. The preparation of the technical file should be carried out in parallel with the MDS development. In the overall, it can be stated that the certification process starts with the conceptualization of the MDS and proceeds all along its design and implementation.

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