AAMI TIR45-2023 Guidance on the use of AGILE practices in the development of medical device software 医疗器械软件开发中使用 AGILE 实践指南.pdf
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AAMI Technical Information Rep。“ AAM I TIR45:2023
Guidance on the use of AGILE practices in the
devel。pment 。f medical device software
Approved 15 March 2023 by
AAMI
Abstract : Over the past several yea rs, AGILE s。由ware devel。pment has bee。me an accepted method for
developing software products . There have been questions from both manufacturers and regulators
as to whether (。r which) AGILE practices are appropriate fo r developing medical device software .
Enough medical device manufacturers have implemented AGILE practices in their softwa re
devel opment s。that answers to these questions can be documented . Having clear gui dance 。f which
practices have been found to be appropriate will be very useful fo r all developers of medical device
s。ftware. This TIR will provide rec。mmendati。ns for c。mplying with internati 。nal standards and U.S.
Food and Drug Admin istrat ion (FDA) guidance documents when using AGILE practices to devel”
medical device software.
Keywords: AGILE, softwa re
AAMI T ec hnical Inform a ti o n R e p ort
A technical information rep。此(TIR) is a publi 臼U。n of the Association for the Advancement of Medical l nstrumentati。n
(AAMI) Standards Board that addresses a particular aspect of medical techn。l ogy.
Although the material presented in a TIR may need further evaluation by expe叫s, releasing the information is va luable
because the industry and the profess ions have an immediate need for it.
A T IR differs markedly from a standard or recommended practice, and readers should understand the differences
between these d。cuments.
Standards and rec。mmended practi 四s are subject to
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