Certification of component-based particle therapy software

The operation of particle therapy facilities requires complex control systems, often spanning several software development environments, each containing large number of applications. While the component-based development approach brings many benefits, institutions often struggle integrating it during the certification process. As part of the technological update of one of its control system environments, the Centro Nazionale di Adroterapia Oncologica (CNAO) treatment center chose to develop the software applications of this environment in a component-based approach, while focusing on strategies to also optimize the certification process. In this document, we examine the challenges of compositional development in the medical software certification process. Additionally, the approach taken by CNAO during the update of one of its control system's environments is presented, along with the evaluation of the expected impact on its certification as medical software.