Medical Device Software: From Requirements to Certification.

Noemi Giordano, Samanta Rosati, Gabriella Balestra
Author Information
  1. Noemi Giordano: Department of Electronics and Telecommunication, Politecnico di Torino, Italy.
  2. Samanta Rosati: Department of Electronics and Telecommunication, Politecnico di Torino, Italy.
  3. Gabriella Balestra: Department of Electronics and Telecommunication, Politecnico di Torino, Italy.

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.

Keywords

MeSH Term

Software
Certification
Delivery of Health Care
Risk Assessment

Word Cloud

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