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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.
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]
The global IEC 62304 standard on the software life cycle processes of medical device software states it is a "software system that has been developed for the purpose of being incorporated into the medical device being developed or that is intended for use as a medical device in its own right."
In software engineering, a software development process or software development life cycle (SDLC) is a process of planning and managing software development. It typically involves dividing software development work into smaller, parallel, or sequential steps or sub-processes to improve design and/or product management .
The waterfall model is the earliest Systems Development Life Cycle approach used in software development. [3] When it was first adopted, there were no recognized alternatives for knowledge-based creative work.
The V-model is a graphical representation of a systems development lifecycle.It is used to produce rigorous development lifecycle models and project management models. The V-model falls into three broad categories, the German V-Modell, a general testing model, and the US government standard.
The ISO/IEC 15288 Systems and software engineering — System life cycle processes is a technical standard in systems engineering which covers processes and lifecycle stages, developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
[8] Part 1 of the standard details SAM processes including control environment, planning and implementation, inventory, verification and compliance, operations management and life cycle. ISO/IEC 19770-2:2015: Software identification tag; [ 9 ] establishes specifications for tagging software to optimize its identification and management.