Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016
Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016
By: Brigid DeCoursey Bondoc and Rachel Park
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA)