AHMED (Agile and Holistic MEdical software Development)

DevOps and continuous development are getting popular in the software industry. Adopting these modern approaches in regulatory environments, such as medical device software, is not straightforward because of the demand for regulatory compliance. While DevOps relies on continuous deployment and integration, regulated environments require strict audits and approvals before releases. Therefore, the use of modern development approaches in regulatory environments is rare, as is the research on the topic. However, as software is more and more predominant in medical devices, modern software development approaches become attractive. This project proposes to seek the fit of DevOps and continuous development for regulated medical device software development.

AHMED final report [PDF]

Events

Medical Device Regulation: from a barrier to a competitive edge – Business Finland