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.