Medical device software - Software life cycle processes
Sets life cycle requirements for medical device software, with a common framework of processes, activities and tasks for developing and maintaining it. It covers software that is a device and software that is part of a device.
Recommended industry standard, listed as current.
The text of this standard is sold by China industry standard (YY) and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
No market listing is published yet.
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 62304, GB/T 25000.51-2016, JIS T 2304, IMDRF GMLP guiding principles, IEC 82304-1. See all standards.
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