This 90-minute course will cover the following objectives; understanding the scope of IEC 62304 to determine how it applies to you; understanding the structure of IEC 62304 so that you can explain to others how your development process satisfies its requirements; recognize the patterns for what IEC 62304 requires so you can address all elements in your development process; and determine how required elements of IEC 62304 can be addressed within an Agile development model.
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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 teh application of AGILE
practices to the medical device world.