Engineering compliance for medical devices has entered a new phase with the FDA Quality Management System Regulation (QMSR) Final Rule, published in January 2024 and effective February 2, 2026. The QMSR replaces the historical Quality System Regulation and incorporates ISO 13485:2016 by reference, harmonizing the U.S. framework with the international framework. For engineers, quality professionals, and regulatory specialists at device manufacturers and contract manufacturing organizations, this transition demands working command of the new framework — not just the text but how it applies in inspections, in CAPA records, and in responses to Form 483 and Warning Letters.

This 16-hour Professional Certificate Course is the entry point of the Aleph Engineering Compliance for Medical Devices course track. It introduces the FDA framework (FFDCA authority, 21 CFR Part 820 / QMSR), the international framework (ISO 13485:2016), and the principal consensus standards integrated with them (ISO 14971:2019 risk management, IEC 60601-1 medical-electrical equipment, IEC 62366-1 usability engineering). The course also orients participants to CAPA under §820.100, complaint handling under §820.198, and the FDA inspection lifecycle (QSIT, Form 483, Warning Letters, consent decrees) at the level needed to understand what these are and how they connect.

The course prepares participants for the Advanced level (`BME-630-A`), where the same content is exercised at applied depth — authoring CAPA records, conducting complaint investigations under §820.198(d), analyzing real publicly available FDA Warning Letters, and authoring a compliance gap analysis. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the compliance vocabulary and the framework that the medical-device industry expects of someone entering a quality, regulatory, or operations role. Employers in this space include medical-device manufacturers across all categories, contract manufacturing organizations, and regulatory and quality consultancies. The Introductory level is the right starting point for professionals whose work touches device compliance but who do not yet have a structured command of the FDA QMSR and ISO 13485 landscape.

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