Diagnostic Grifols: Being Agile While Still Being Compliant
Wednesday, 29 May 2013, 1:00 PM ET/ 10:00 AM PT/ 17:00 UTC/GMT === Although Medical Device regulations do not enforce a fixed life cycle model, activities are presented in a sequential manner hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from Agile development methods. There’s a number of Medical Device manufacturers that have adopted Agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. AAMI’s new Technical Information Report (TIR45) gives guidance on the use of Agile in medical device development. This TIR adds new insights on the subject by mapping IEC 62304 (medical device software dev) activities into the Agile development process.