Roy Tuason

Roy Tuason is director of SQA Engineering for Zap Surgical. He holds a degree in applied mathematics and computer science and has 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 Scaled Agile change agent, he guided international development organizations’ transitions to scaled agile (SAFe). Prior to this he was a Gunnery Sergeant, a Platoon Sergeant, and the Operations Chief for 155mm artillery fire direction control in the Marine Corps.

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Using Agile to Navigate through Medical Device Regulations

When you test medical device software, you must be very careful. But when development wants to push a cadence of two weeks per sprint, every sprint, you’ve just got to keep up! Interpret the regulatory requirements not as a set of disabling constraints, but as a challenge to find the optimal route to navigate through.