A novel taxonomy of Agile roles, ceremonies, and artefacts for medical software development has been developed. The findings identify 39 empirically derived practices that enable the systematic integration of regulatory and safety-critical requirements into Agile workflows.This replication dataset provides resources for this qualitative, multi-method research project involving in-depth interviews with 30 Agile practitioners from the UK, Nigeria, and India, recruited using snowball sampling. A novel practice-based process model was developed. The model was evaluated by eight Agile practitioners in the UK and Nigeria. The model was applied to a case study involving Nigerian practitioners managing a Canadian medical software project.