‘Tiny Tentacles of Risk’: Under FDA’s New QMSR, MedTech Companies Must Embed Risk Management Into Their Culture

By Shawn M. Schmitt Communications Specialist, Enzyme When the US Food and Drug Administration (FDA) begins auditing MedTech companies under the new Quality Management System Regulation (QMSR) in 2026, the agency’s facility investigators will be looking for more than simply ticking off compliance checkboxes. They will expect companies to demonstrate a culture of quality, where…