F4: Agile Development and Risk Based Control of Complex Medical Device Systems - Dr. Byron Mattingly - (Intermediate)

This session focuses on integrating risk management and control with agile and lean software development techniques to drive robustness and reliability for the entire product lifecycle of complex medical device systems.  Because such systems are inherently non-linear, risk management must take into account how small events can have enormous consequences that can happen quite suddenly, and often in unexpected ways.  Special attention is given to applying the FDA’s draft guidance for Mobile Medical Applications when validating and qualifying processes for the Apple iPad and Android based tablets.