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Wednesday, October 15, 2014 - 1:45pm - 2:45pm
Agile Testing
W10

Agile Development and Testing in a Regulated Environment

One of the Agile Principles states that working software is the primary measurement of success―generally measured by the level of customer satisfaction. So, how do you measure “customer satisfaction” when it is based on successful surgical outcomes? Join John Pasko as he takes you through a case study of the design, development, testing, and release of a complex system—integrating embedded software with hardware—for a surgical product which met stringent FDA standards and regulations. Cross-functional teams comprised of Product Owners, software engineers, and QA engineers used agile, TDD, continuous integration, and automated and manual acceptance testing to create iterative in-house releases to our Product Owner—the internal customer. When all requirements and standards were satisfied, we released the completed product for use in medical facilities. Learn how we satisfied regulatory requirements and provided an audit trail by using a formal tool to map requirements, handle change requests, and monitor defects and their corresponding fixes.

John Pasko, Karl Storz Imaging

With more than seventeen years of experience at companies ranging from government agencies and consulting firms to medical-device companies, John Pasko has been agile since introduced to XP and test-first methodologies in 2001. Practicing Scrum for five years, John is currently a software engineer in Speech Recognition Technology at Karl Storz Imaging (KSI). Since joining KSI in 2011, he has worked with the OR1 Team on cutting edge surgical software. John has provided guidance on TDD practices and introduced Mob Programming to the KSI development team.

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