MLOps-Driven Automation of Regulatory Documentation for AI-Based Medical Software

In recent years, the increasing integration of AI within clinical software has led to the emergence of Software as a Medical Device (SaMD), a category of systems subject to strict regulatory oversight. A major challenge for developers in this domain is the continuous production of regulatory documentation, which remains largely manual and disconnected from development pipelines. This paper proposes a strategy to automate documentation generation by embedding MLOps principles—such as traceability, reproducibility, and continuous integration—into the development workflow. Applied to a representative healthcare AI project, the approach produced consistent, audit-ready artefacts with minimal manual effort, demonstrating its potential to narrow the gap between rapid innovation and regulatory compliance.