Principles of ISO 13485:2016 for Medical Device Safety

Working in her garden, Maria’s insulin pump experiences an error that sends her to the hospital and GlucoGuard’s engineers, the makers of Maria’s pump, on a critical quest to uncover the root cause of the device’s failure. Using ISO 13485:2016 as their north star, the actions of the staff at GlucoGuard illustrate how their quality management system (QMS) functions in practice. From organizational structures and guidelines like the document pyramid and Good Documentation Practices (GDoC) to high-stakes Adverse Event reporting, you’ll learn how ISO 13485’s international standards transform paperwork into a life-saving net. Along the way, we’ll break down complex regulatory requirements into actionable insights. We’ll explore Verification and Validation, root cause analysis tools, and see how the CAPA system leads to systemic improvements.