Medical-device labeling is not a cosmetic formality: it is one of the QMS processes the FDA inspects most often, a frequent source of Warning Letters and recalls, and the primary vehicle by which a manufacturer communicates safe and effective use to the user. Under the FD&C Act, inadequate labeling can turn a perfectly manufactured device into a misbranded or adulterated product. The FDA transition to QMSR (effective February 2, 2026), which incorporates ISO 13485:2016 by reference, reinforces the integration of labeling, the QMS and risk management.

This instructor-led online course teaches medical-device labeling as a process woven through the entire Quality Management System, using labeling as the vehicle to introduce the U.S. regulatory framework (FD&C Act, 21 CFR 800–898) and the harmonized international standards (ISO 13485:2016, ISO 14971, ISO 20417, ISO 15223). Students progress from definitional foundations (label vs. labeling, UDI, intended use vs. indications for use) through device classification and premarket pathways, the legal doctrines of adulteration and misbranding, the ISO 13485 architecture and SOP authoring, the substantive rules of ISO 20417 / ISO 15223, and ISO 14971 risk-management discipline with a hands-on Risk Assessment Categorization Tool (RACT).