This 90-minute course provides an overview of regulatory context for requirements, systems engineering/product development context for requirements, requirements engineering life cycle, traceability and Agile requirements.
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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.