A Case Study on Tailoring SafeScrum to a Medical Device Software Organization

Sammanfattning: As a type of safety-critical systems, medical devicesneed to undergo a certification process to ensure their safety,which entails a significant amount of documentation. This approachis in stark contrast with the focus on shorter time-tomarketand flexibility to change that agile strives to achieve. Toovercome this challenge of accommodating documentation-heavycertification requirements within the agile approach, SafeScrumwas modified from the agile method Scrum. However, afterreviewing the related literature, we found that SafeScrum hasnot been adapted or applied to the medical domain as of yet. Tobridge this gap in knowledge, we are conducting a case study thatuses observations, interviews, workshops and thematic analysis.The purpose of our research is to understand how to adaptSafeScrum to a safety-critical medical device organization andseveral of the standards the organization needs to comply with.We also focus on what gaps we can find in SafeScrum and whatmethod content from SafeScrum is not required either by thestandards we investigated, or by the case organization.Keywords—SafeScrum, Agile, Safety-Critical Medical