Towards Agile Yet Regulatory-Compliant Development of Medical Software

Abstract

As digital transformation is taking place in more and more industries, the role of software increases and the skills required to develop software trigger a ripple effect. Entire industries, where regulations and government standards play an important role, like health care, have used long development cycles that relied on detailed planning. Agile software development proved that it can deliver results that satisfy customers needs faster than traditional waterfall methodologies. The apparent conflict between fast delivery cycles and lack of detailed planning have lead to situations where the use of agile became synonymous with lack of documentation and poor quality. In this paper we propose new approaches that demonstrate that appropriate use of agile practices brings benefits to compliance activities too.