Conformance to Medical Device Software Development Requirements with XP and Scrum Implementation

A key challenge of medical device software development companies is to maintain both conformance to the strict regulatory requirements enforced by the safety critical nature of the domain and achieve efficiency in software development. Agile software development methods provide promising solutions to overcome the efficiency issues and the challenges of traditional software development approaches. Even though Agile practices are being welcomed by the medical domain, their suitability for conformance to the regulatory requirements is still being questioned by the medical industry. In our previous work, we investigated to what extent the regulatory requirements defined in MDevSPICE® (the software process assessment framework for medical device software development) are met through using a Scrum implementation and what additional practices have to be performed to ensure safety and regulatory compliance in the medical domain. In this paper, we extended the research to include the XP method and provide a comprehensive and quantitative analysis of its suitability for medical device software development