How does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE

Medical device software development is subject to high regulations due to the potential risk of harming patients with unsafe medical devices. These regulations require software development to be performed with high discipline and evidence to be provided for auditory purposes. It’s not easy to manage both conformance to regulations and efficiency in medical device development. Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time to market, improve customer and employee satisfaction and ensure both safety and reliability. In this study, we evaluated one of the most highly adopted agile software development methods, Scrum from a regulatory perspective. We investigated to what extend the regulatory requirements defined in MDevSPICE® are met with implementation of the Scrum method and what additional processes and practices have to be performed to ensure safety and regulatory compliance in the healthcare domain.