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IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.
ISO/IEC/IEEE 12207 Systems and software engineering – Software life cycle processes [1] is an international standard for software lifecycle processes. First introduced in 1995, it aims to be a primary standard that defines all the processes required for developing and maintaining software systems, including the outcomes and/or activities of each process.
A systems development life cycle is composed of distinct work phases that are used by systems engineers and systems developers to deliver information systems.Like anything that is manufactured on an assembly line, an SDLC aims to produce high-quality systems that meet or exceed expectations, based on requirements, by delivering systems within scheduled time frames and cost estimates. [3]
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance. The HL7 standards focus on the application layer, which is "layer 7" in the Open Systems Interconnection model.
V-Model – model, which defines the software development lifecycle and test process. ISO 9000 – family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders[1] while meeting statutory and regulatory requirements related to the product.
Health Level Seven International (HL7) is a non-profit ANSI-accredited standards development organization that develops standards that provide for global health data interoperability. The 2.x versions of the standards are the most commonly used in the world.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.