Course 1: Software Online Agile Regulatory Training Overview
This is a 90-minute course that provides an overview of topics such as Medical Device and Software; US FDA and EU Regulation of Medical Devices; FDA Software Development Guidance; IEC 62304 Software Life Cycle Processes; ISO 14971 Risk Management Standard for Medical Devices; and Medical Device Regulation and Agile.
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Access for24 weeks
Owner, Agile Quality Systems & a Principal Author of AAMI
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 the application of AGILE
practices to the medical device world.