Nancy Van SchooenderwoertPresident and Managing Partner
Nancy Van Schooenderwoert does agile enterprise coaching— everything from launching new agile technical teams to advising executives on how to take agile and lean principles far beyond software development in their drive to deliver more customer value faster. She works with large and small companies. Nancy pioneered agile practices for embedded software development beginning in 1998. Her background in electronics and software development for avionics, factory automation, medical, and defense systems brings a unique perspective to her coaching practice.
1:30 PM WORKSHOP B: AN INCREMENTAL APPROACH TO RISK AND QUALITY MANAGEMENT IN MEDICAL DEVICE SOFTWARE DESIGN
Software Engineers are dedicated to making things work, so a focus on failure can be unusual. However, risk management is essential for all medical devices, especially those involving software. There are many examples that software failures have produced some painful examples of poor risk management with serious consequences.
· Understand “Safety Hazards” related to software
· Evaluate the intersection of medical device standards and their intersection with risk management
· Assess End users and Human Factors to improve safety
· Apply engineering risk methods to software design concepts
· Draw a roadmap for effective risk management
•Experience that both quality and safety are improved when the software development team is agile, and that regulatory requirements can still be met
•Delve into several key areas for applying Agile methods in the medical device context
•Fit together hardware and software development, and being Agile in both