Medical-device labeling is not a cosmetic exercise. Labeling is one of the QMS processes FDA inspects most frequently, one of the most common drivers of Warning Letters and recalls, and the principal vehicle by which a manufacturer communicates safe and effective use to the user. Under the Federal Food, Drug, and Cosmetic Act, inadequate labeling can convert a perfectly manufactured device into a misbranded or adulterated product, with serious regulatory consequences. The FDA QMSR Final Rule (effective February 2, 2026), which incorporates ISO 13485:2016 by reference, reinforces the integration between labeling, QMS, and risk management.

This 16-hour Professional Certificate Course is the entry point of the Aleph Medical Device Labeling Regulation course track. It introduces the statutory and regulatory vocabulary of medical-device labeling — what a “label” is under §201(k) of the FD&C Act, what “labeling” is more broadly, what UDI (Unique Device Identification) is and how it decomposes into Device Identifier (DI) and Production Identifier (PI), and the critical distinction between “intended use” and “indications for use”. The course also orients participants to the legal doctrines of adulteration (§501) and misbranding (§502), and to the principal international standards that govern labeling content and symbols (ISO 13485:2016 quality-management context, ISO 20417 manufacturer information, ISO 15223-1/-2 symbols).

The course prepares participants for the Advanced level (`RAQ-514-A`), where the same content is exercised at applied depth — SOP authoring under ISO 13485, label audit against ISO 20417 and ISO 15223-1, RACT (Risk Assessment Categorization Tool) practicum, CAPA-loop integration with labeling changes, and an open-book final assessment. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the vocabulary the medical-device industry expects of someone managing or auditing labeling — terminology that recurs in every 510(k), every label audit, every CAPA related to labeling, and every Warning Letter that cites §801. Employers in this space include medical-device manufacturers, consultancies serving manufacturers, labeling translation and multilingual specialists, and UDI compliance teams.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.