AAMI TIR45:2012/(R)2018

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

Association for the Advancement of Medical Instrumentation , 08/20/2012

Publisher: AAMI

File Format: PDF

$137.00$275.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 08/20/2012

Published:08/20/2012

Pages:74

ISBN(s):1570204454

File Size:1 file , 1.4 MB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.