May 3, 2012, 6:00 pm - 9:00 pm,
, Waltham, MA: REGISTRATION IS REQUIRED
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Conventional wisdom holds that the FDA prefers to see medical device manufacturers use a sequential, waterfall lifecycle for product and software development. The result has led many companies to bend and twist the process they actually use so that it looks like a linear process to their regulators. No one is fooled and these efforts mainly add overhead and waste. More importantly, they do little to improve the safety and effectiveness of their products.
A growing number of medical device companies are adopting, and adapting, agile principles and practices for the development of regulated software; not just to improve efficiency, but also safety and effectiveness. This session will explore how to apply agile principles in a way that is consistent with FDA regulations and guidance; how agile and XP practices can be used to reduce risk and improve safety; which practices need modification to support the demands of safety critical software; and how these have been applied on real projects to achieve compliance.
About the speaker:
Mike Attili - President of Amaxo, Inc.
Mike’s background features over 25 years of experience in software engineering for medical, pharmaceutical, and laboratory instrumentation companies such as Applied Biosystems, Delmar-Reynolds, Parker Life Sciences, and Helicos BioSciences. Mike most recently led the software development effort for a new, large volume infusion pump as the VP of Software Development for Fluidnet. Mike is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Software Standards Committee that is currently finalizing guidance on the use of agile practices in the development of medical device software.