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12 Δεκ 2022 · The IEC 62304 defines the software life cycle (SLC) as a conceptual structure, including its lifetime from the requirements’ definition until the release. It describes processes, tasks, and activities involved in developing a software product and their order and interdependencies.
22 Ιαν 2024 · The Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes.
22 Δεκ 2022 · The IEC 62304 defines the software life cycle (SLC) as a conceptual structure, including its lifetime from the requirements’ definition until the release. It describes processes, tasks, and activities involved in developing a software product and their order and interdependencies.
Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
4 Νοε 2021 · IEC 62304 is the international standard for medical device software development and other medical device software life cycle processes. Every caution is needed to ensure the safety of patients...
The term health software is defined to include all software used for managing, maintaining, or improving the health of individual persons, or the delivery of care, still also including the software in medical devices.
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.
