CompliancePal: A Tool for Supporting Practical Agile and Regulatory-Compliant Development of Medical Software

Abstract

As digital transformation affects more and more industries, the increased role of software and the skills required to develop software trigger a ripple effect. Entire industries, where regulations and government standards play an important role (e.g. health care, avionics, etc.), have used long development cycles that relied on detailed up-front planning before advancing to any detailed decision. In contrast to this mindset, agile software development has proven to deliver results that satisfy customers needs faster than traditional waterfall methodologies. The lack of detailed upfront planning and fast delivery cycles have led to situations where the use of agile became synonymous with lack of documentation and poor quality, and hence the perception that the approach is not suitable for regulated systems. In this experience paper we describe the implementation of a service that integrates medical device software compliance specific activities such as architectural design and limited risk management into the daily agile practices of a software development team.