This 90-minute course on Software Development Planning reviews the understanding of the regulatory requirements and standards related to Planning; Learning the content to be considered for a Software Development Plan such as Development Strategies, Software Development and Supporting Processes and Documentation; and Addresses the impact that the use of Agile methods has on a Software Development Plan.
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Access for24 weeks
Owner, Agile Quality Systems & a Principal Author of AAMI TIR45
As one of the principal authors of AAMI TIR45 "Guidance on the use of
AGILE practices in the development of medical devices software", Kelly
has worked with the FDA and industry leaders on teh application of AGILE
practices to the medical device world.