Tailoring MDevSPICE® for Mobile Medical Apps

Mobile medical apps play an important role within the healthcare industry. Developers of mobile medical apps need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers as medical device software is normally developed with a focus upon producing the regulatory documentation that is essential to market such devices. Regulatory compliance is usually achieved by adopting a plan-driven software development approach, which is not typically the method used to develop mobile applications. MDevSPICE (R) is a medical device software process framework that integrates processes from various medical device software and generic software development best practice standards. In this paper the authors describe how the MDevSPICE (R) framework can be tailored to support mobile medical applications development by introducing agile practices into the framework.