Explore the key software development practices that support Quality Management Systems (QMS) for Software as a Medical Device (SaMD). Learn how traceability, verification and validation can help build safe, reliable and well-documented medical software.
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Written by experts
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Introductory
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100% online
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Video content
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Multiple choice quiz
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Approx. 3 hours to complete
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Completion certificate
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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.
This course is for you if you are:
A health or care professional, researcher, student, patient, or if you are interested in quality management systems and software development.
This course is open access and asynchronous (you can complete it in your own time).
At the end of this course, upon completion of all sections including activities, a certificate will be awarded.
Thank you to the following who helped develop and fund this course:
- The King's Health Partners Digital Health Academy https://digitalhealthtraining.kcl.ac.uk/
- The Engineering and Physical Sciences Research Council (EPSRC) for the funding that made this course
- Marc Modat - Reader in Computational Imaging
If you have any enquiries or feedback regarding this course please contact traininghub@kcl.ac.uk
