FDA’s deadline to the Quality Management System Regulation (QMSR)—harmonizing with ISO 13485:2016 – February 2, 2026
FDA’s deadline to the Quality Management System Regulation (QMSR)—harmonizing with ISO 13485:2016 – February 2, 2026 The Kent Group: Audit Integrity in the QMSR Era If your suppliers are still operating on legacy QSR checklists, your 2026 market access is already at risk. In this new regulatory landscape, a “generic” GMP audit is a liability. […]

