AAMI TIR45-2012

Guidance on the use of AGILE practices in the development of medical device software

AAMI TIR45-2012 发布历史

Over the past several years, agile software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) agile practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented agile practices in their software development so that answers to these questions can be documented. Having clear guidance of which practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and U.S. Food and Drug Administration (FDA) guidance documents when using agile practices to develop medical device software.

AAMI TIR45-2012由US-AAMI 发布于 2012-08-20。

AAMI TIR45-2012的历代版本如下：

• 2012年08月20日 AAMI TIR45-2012

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标准号

AAMI TIR45-2012

发布日期

2012年08月20日

实施日期

废止日期

无

发布单位

US-AAMI

适用范围

Over the past several years, agile software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) agile practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented agile practices in their software development so that answers to these questions can be documented. Having clear guidance of which practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and U.S. Food and Drug Administration (FDA) guidance documents when using agile practices to develop medical device software.