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Metamodel for Safety Risk Management of Medical Devices Based on ISO 14971

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Model-driven engineering

Model-driven engineering (MDE) is a software development methodology that focuses on creating and exploiting domain models, which are conceptual models of all the topics related to a specific problem. Hence, it highlights and aims at abstract representations of the knowledge and activities that govern a particular application domain, rather than the computing (i.e. algorithmic) concepts. MDE is a subfield of a software design approach referred as round-trip engineering.

Wearable technology

Wearable technology is any technology that is designed to be used while worn. Common types of wearable technology include smartwatches and smartglasses. Wearable electronic devices are often close to or on the surface of the skin, where they detect, analyze, and transmit information such as vital signs, and/or ambient data and which allow in some cases immediate biofeedback to the wearer.

Model-based systems engineering

Model-based systems engineering (MBSE), according to the International Council on Systems Engineering (INCOSE), is the formalized application of modeling to support system requirements, design, analysis, verification and validation activities beginning in the conceptual design phase and continuing throughout development and later life cycle phases. MBSE is a technical approach to systems engineering that focuses on creating and exploiting domain models as the primary means of information exchange, rather than on document-based information exchange.

Component-based software engineering

Component-based software engineering (CBSE), also called component-based development (CBD), is a branch of software engineering that emphasizes the separation of concerns with respect to the wide-ranging functionality available throughout a given software system. It is a reuse-based approach to defining, implementing and composing loosely coupled independent components into systems. This practice aims to bring about an equally wide-ranging degree of benefits in both the short-term and the long-term for the software itself and for organizations that sponsor such software.

Operational risk management

Operational risk management (ORM) is defined as a continual recurring process that includes risk assessment, risk decision making, and the implementation of risk controls, resulting in the acceptance, mitigation, or avoidance of risk. ORM is the oversight of operational risk, including the risk of loss resulting from inadequate or failed internal processes and systems; human factors; or external events. Unlike other type of risks (market risk, credit risk, etc.) operational risk had rarely been considered strategically significant by senior management.

Object Process Methodology

Object process methodology (OPM) is a conceptual modeling language and methodology for capturing knowledge and designing systems, specified as ISO/PAS 19450. Based on a minimal universal ontology of stateful objects and processes that transform them, OPM can be used to formally specify the function, structure, and behavior of artificial and natural systems in a large variety of domains. OPM was conceived and developed by Dov Dori. The ideas underlying OPM were published for the first time in 1995.

Wear OS

Wear OS (also known simply as Wear and formerly Android Wear) is a version of Google's Android operating system designed for smartwatches and other wearables. By pairing with mobile phones running Android version 6.0 "Marshmallow" or newer, or iOS version 10.0 or newer with limited support from Google's pairing application, Wear OS integrates Google Assistant technology and mobile notifications into a smartwatch form factor. Wear OS supports Bluetooth, NFC, Wi-Fi, 3G, and LTE connectivity, as well as a range of features and applications.

Enterprise systems engineering

Enterprise systems engineering (ESE) is the discipline that applies systems engineering to the design of an enterprise. As a discipline, it includes a body of knowledge, principles, and processes tailored to the design of enterprise systems. An enterprise is a complex, socio-technical system that comprises interdependent resources of people, information, and technology that must interact to fulfill a common mission.

Information and communications technology

Information and communications technology (ICT) is an extensional term for information technology (IT) that stresses the role of unified communications and the integration of telecommunications (telephone lines and wireless signals) and computers, as well as necessary enterprise software, middleware, storage and audiovisual, that enable users to access, store, transmit, understand and manipulate information. ICT is also used to refer to the convergence of audiovisuals and telephone networks with computer networks through a single cabling or link system.

Health information technology

Health information technology (HIT) is health technology, particularly information technology, applied to health and health care. It supports health information management across computerized systems and the secure exchange of health information between consumers, providers, payers, and quality monitors. Based on a 2008 report on a small series of studies conducted at four sites that provide ambulatory care – three U.S.