Agile software development has become increasingly popular in recent years. Applying agile methods, companies expect flexible planning, early deliv-ery of the software product, and a continuous improvement of the development process itself. However, in regulated environments the use of agile development is not yet common practice. In such environments, various regulatory require-ments apply which affect the software development process. This paper examines the use of agile software development in the regulated medical device industry and explores reasons for using agile methods although their use is limited. We interviewed agile software development teams in three different companies using semi-structured interviews. Using grounded theory methodology, we identify reasons why companies are using agile methods, even though problems and bar-riers exist. Our main achievement is the development of four categories, which describe the benefit of agile software development in regulated environments. These categories are master complexity, reduce effort, improve usability, and promote collaboration.     «

Agile software development has become increasingly popular in recent years. Applying agile methods, companies expect flexible planning, early deliv-ery of the software product, and a continuous improvement of the development process itself. However, in regulated environments the use of agile development is not yet common practice. In such environments, various regulatory require-ments apply which affect the software development process. This paper examines the use of agile software development i...     »