Navigating the QMSR Transition: Aligning CAPA Processes with ISO 13485 and FDA Requirements
Navigating regulatory compliance often feels like traversing a labyrinth filled with standards and requirements that demand precision and vigilance. The FDA’s upcoming transition to the Quality Management System Regulation (QMSR) aims to harmonize FDA requirements for medical devices with international standards, particularlyc. This shift introduces new complexities, particularly in handling Corrective and Preventive Actions (CAPA). […]
New QMSR Risk Management Transition
Introduction to the QMSR Risk Management Transition The initial articles in this series focused on key differences a company needs to be aware of as they transition from the Quality System Regulation (QSR) to the Quality Management System Regulations (QMSR). For article 1 in this series that focuses on the QMSR introduction, click here. For […]
QMSR Transition Definitional Differences: Important Guide
Definitions matter. In cases of compliance, they matter a lot. That is why it is worth spending some focused time reviewing the QMSR transition definitional differences being implemented. As stated in my prior article (click here for article #2 in this series), Definitional Differences In section 3 “Terms and Definitions,” ISO 13485:2016 has 19 entries, […]
Important Differences: 21 CFR 820 QSR transition to QMSR
From the Top: Key Differences in the QSR transition to QMSR This is the second in a series of articles concerning the FDA’s proposal to transition 21 CFR 820 from the Quality System Regulation (QSR) into the Quality Management System Regulation (QMSR) by incorporating the ISO 13485:2016 standard by reference. To read the first article in this […]
Transitioning to the Medical Device Quality Management System Regulation (QMSR)
This is the first in a series of articles on the new Quality Management System Regulation (QMSR). The QMSR was published as a final rule on January 31, 2024 with an effective date of February 2, 2026. This series is intended to help companies fully prepare for the complicated journey ahead. Quality Management System Regulation […]
