The Quality Management System Regulation (QMSR)
After more than two decades of discussions about aligning global medical device quality system standards, the FDA has published its final rule for the Quality Management System Regulation (QMSR). Released in February 2024, this rule brings the current Quality System Regulation (QSR) for medical devices into closer alignment with the international standard, ISO 13485. Medical device manufacturers have until February 2, 2026, to comply with the QMSR.
The QMSR incorporates ISO 13485 standards, with only a few U.S.-specific requirements. If your Quality Management System (QMS) already complies with both the U.S. QSR and ISO 13485, your transition to the new QMSR should be relatively straightforward. However, if your QMS is based solely on the U.S. QSR, the most significant change will be incorporating risk management activities and adopting a risk-based approach. In either case, we recommend the following steps to ensure you're compliant by the February 2, 2026, deadline:
Conduct a gap assessment to identify areas where your QMS differs from the QMSR.
Develop a quality plan to evaluate and map out the necessary changes.
Revise QMS processes in collaboration with cross-functional teams.
Implement the changes, including training for impacted staff.
Perform an internal audit to confirm compliance with the QMSR.
Need assistance?
Our team can help you navigate this transition smoothly. Whether you need a gap assessment, support in developing a comprehensive quality management system, staff training, or an audit, we have the expertise to guide your organization through the process.