Software as a Medical Device (SaMD) requires robust development processes to demonstrate quality, safety and effectiveness.
This course introduces the role of Quality Management Systems (QMS) in SaMD development and focuses on three key areas: traceability, verification and validation.
You will explore how development activities can be documented and tracked, how software can be tested against specified requirements, and how reproducible software environments can support validation. Practical software development approaches—including repository organisation, version control, testing, automated quality checks, CI/CD, dependency management and containerisation—are introduced throughout the course to demonstrate how quality can be built into the software development lifecycle.
