This paper presents the Mechanical Ventilator Milano (MVM), a novel intensive therapy mechanical ventilator designed for rapid, large-scale, low-cost production for the COVID-19 pandemic. Free of moving mechanical parts and requiring only a source of compressed oxygen and medical air to operate, the MVM is designed to support the long-term invasive ventilation often required for COVID-19 patients and operates in pressure-regulated ventilation modes, which minimize the risk of furthering lung trauma. The MVM was extensively tested against ISO standards in the laboratory using a breathing simulator, with good agreement between input and measured breathing parameters and performing correctly in response to fault conditions and stability tests. The MVM has obtained Emergency Use Authorization by U.S. Food and Drug Administration (FDA) for use in healthcare settings during the COVID-19 pandemic and Health Canada Medical Device Authorization for Importation or Sale, under Interim Order for Use in Relation to COVID-19. Following these certifications, mass production is ongoing and distribution is under way in several countries. The MVM was designed, tested, prepared for certification, and mass produced in the space of a few months by a unique collaboration of respiratory healthcare professionals and experimental physicists, working with industrial partners, and is an excellent ventilator candidate for this pandemic anywhere in the world.

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Medical devices are safety-critical systems since their malfunctions can seriously compromise human safety. Correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards. However, these standards provide general descriptions of common software engineering activities without any indication regarding particular methods and techniques to assure safety and reliability. This paper discusses how to integrate the use of a formal approach into the current normative for the medical software development. The rigorous process is based on the Abstract State Machine (ASM) formal method, its refinement principle, and model analysis approaches the method supports. The hemodialysis machine case study is used to show how the ASM-based design process covers most of the engineering activities required by the related standards, and provides rigorous approaches for medical software validation and verification.

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In the context of automotive domain, modern control systems are software-intensive and have adaptive features to provide safety and comfort. These software-based features demand software engineering approaches and formal methods that are able to guarantee correct operation, since malfunctions may cause harm/damage. Adaptive Exterior Light and the Speed Control Systems are examples of software-intensive systems that equip modern cars. We have used the Abstract State Machines to model the behaviour of both control systems. Each model has been developed through model refinement, following the incremental way in which functional requirements are given. We used the ASMETA tool-set to support the simulation of the abstract models, their validation against the informal requirements, and the verification of behavioural properties. In this paper, we discuss our modelling, validation and verification strategies, and the results (in terms of features addressed and not) of our activities. In particular, we provide insights on how we addressed the adaptive features (the adaptive high beam headlights and the adaptive cruise control) by explicitly modelling their software control loops according to the MAPE-K (Monitor-Analyse-Plan-Execute over a shared Knowledge) reference control model for self-adaptive systems.