CHALLENGES OF AGILE PRACTICES IMPLEMENTATION IN THE MEDICAL DEVICE SOFTWARE DEVELOPMENT METHODOLOGIES
CHALLENGES OF AGILE PRACTICES IMPLEMENTATION IN THE MEDICAL DEVICE SOFTWARE DEVELOPMENT METHODOLOGIES

Summary/Abstract: Agile practices have transformed many segments of the software development industry by streamlining the development process. Medical Device industry is facing new challenges as software is taking a more dominant role and the established development methodologies are struggling to meet the growing demand for rapidly produced high quality software. This paper presents review of the available literature on the subject of introducing the Agile practices in the Medical device industry with the aim to systematically point out the advantages, challenges and possible approaches to this process. Most challenges for embracing the Agile methodologies in the Medical Device industry seem to be rooted in the fact that the industry is regulated and Agile was not originally intended to address such processes. However, there are success stories from this and other regulated industries showing that implementation of selected Agile practices into the existing frameworks can be very beneficial.

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