Safety-Critical Software the Quality Agilist’s Way

Roy Tuason

Delivering hundreds of laser beams to brain tumors with sub-millimeter precision requires accurate, safe, and effective software that is developed and tested carefully and meticulously. But to be competitive in the market and responsive to customer needs you’ve got to be fast. How do you satisfy this contradiction? How do you know when the software is ready? When is good enough, truly good enough? Are you fast enough, and are you compliant? In two-week sprints, Zap Surgical develops software for planning brain cancer treatments, and then delivering those treatments on its new gyroscopic machine. See how optimizing design control process and tooling enables Zap Surgical to meet these constraints and deliver high quality software to treat brain cancer patients needing a cure. As Wyatt Earp said: “Fast is fine but accuracy is final.”

About the Presenter

Roy Tuason is director of SQA Engineering for Zap Surgical Systems and holds a degree in applied mathematics and computer science. He has over twenty years of medical device experience, including quality engineering and regulatory compliance in the cancer fields of stereotactic radiosurgery, chemotherapy administration, and oncology information systems. As a quality assurance manager and certified SPC (SAFe Scaled Agile Program Consultant) he guided international development organizations transitioning to the scaled agile framework. Prior to this he was a Gunnery Sergeant and Operations Chief for 155 artillery fire direction control in the Marine Corps.


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