Browsing by Subject "standard"

Introduction: EU medical device regulation (MDR) sets requirements for medical device software (MDSW) development. Following international standards, such as IEC 62304 and IEC 82304-1, is considered best practice to ensure compliance with regulation. At first glance, MDR and standards seem counter-intuitive to the DevOps approach. DevOps has been successful in regular software development, and it could improve MDSW development. In addition, standalone software is more prevalent as a medical device and as software does not need to be embedded into a physical device, the DevOps approach should be more feasible. Methods: In this thesis, a systematic approach of multivocal literature review was conducted. The goal is to find the state-of-the-art of DevOps in MDSW development, what DevOps techniques and practices are suggested by academic literature and industry experiences, and what the challenges and benefits of DevOps are in MDSW. 18 scientific articles and 10 sources of gray literature were analyzed. Results: The DevOps benefits of improved quality and faster release cycle can be achieved up to a certain point. Regulations prevent Continuous Deployment, but Continuous Integration (CI) and Continuous Delivery (CD) are possible. The most promising improvements can be made by automated documentation creation and bringing tasks of regulatory experts and developers closer together by streamlining the regulatory process. Existing DevOps tools can be extended to support compliance requirements. Third-party platforms and AI/ML solutions remain problematic due to regulations.