Training

QHub Brief║From Training Records to Employee Competence: Understanding QMSR & ISO 13485 Expectations for Makers of Medical Devices

July 21, 2026

This QualityHub Expert Brief examines the evolution of training requirements for makers of medical devices, highlights key differences between the former Quality System Regulation (QSR)

QHub Insights║The Evolution of Medical Device Industry Training Requirements

February 24, 2026

With the introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485