Risk-based Comprehensive Usability Evaluation of Software as a Medical Device

Abstract

Introduction: Usability evaluation is a core aspect in risk assessment of medical devices, as it aims to ensure the device interface safety, avoiding that usability problems at interface level are not related to harm. Methods: Our research group applied our risk-based approach, international reference standards and guidelines to the usability evaluation of a large family of SaMD. The methodology used for the evaluation is an elaboration of regulatory prescriptions and is composed of a combination of quantitative and qualitative methods. In particular, the usability evaluation is structured in a two-stage evaluation composed by formative and summative evaluation. The formative stage is propaedeutic for the planning of the summative evaluation. The final assessment included the analysis of quantitative data collected through three questionnaires and a