Agile Software Development

Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. The research that has been conducted in agile software development includes:
• Integrating agile practices with a traditional plan-driven SDLC.
• Extending the MDevSPICE® framework with agile practices to enable medical device software development to be performed in a more flexible manner. MDevSPICE® is a medical device software process assessment framework that integrates the regulatory requirements from the relevant medical device software standards.