Tailoring MDevSPICE® for mobile medical apps
Kitija Trektere, Fergal McCaffery, Marion Lepmets, Grainne Barry · 2016
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® 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® framework can be tailored to support mobile medical applications development by introducing agile practices into the framework.