The Quality Management System (QMS) is the operational backbone of every medical-device manufacturer. FDA 21 CFR Part 820 and ISO 13485:2016 set the essential requirements for designing, manufacturing, distributing and monitoring devices safely and effectively. With the FDA Quality Management System Regulation (QMSR) Final Rule effective February 2, 2026, the U.S. and international frameworks are formally harmonized — a new operational layer quality professionals must master.

This instructor-led online course teaches you to read ISO 13485:2016 clause by clause and map each to a QMS procedure; to read 21 CFR Part 820 alongside ISO 13485 in light of the 2026 QMSR harmonization; and to author real QMS deliverables — a Manufacturing Quality Control Plan, an Inspection Test Plan, a Material Review Board procedure, a Design and Development Plan, an FMEA, an internal-audit schedule, a customer-complaint record and a supplier-audit plan. It is organized around the four FDA QMS subsystems — Production and Process Controls, Design Controls, Management, and CAPA — and applies ISO 14971 risk management to a chosen device.