The FDA reissues its cybersecurity guidance to align with the new QMSR
February 20, 2025
The U.S. Food and Drug Administration has reissued its cybersecurity guidance to align with the new Quality Management System Regulation (QMSR).
What this signals:
• Cybersecurity is now fully embedded within quality system expectations
• Alignment with ISO 13485 is no longer theoretical; it’s operational
• Lifecycle risk management and traceability are central to submission readiness
For software-enabled and AI-driven devices, cybersecurity can’t sit in a silo. It must be integrated into design controls, risk frameworks, and validation strategy from the start.
Let Freelong Health assess and align your QMS architecture, verification strategy, and cybersecurity documentation so systems are regulator-ready.
#MedicalDevices #Cybersecurity #QMSR #ISO13485 #SaMD #DigitalHealth
