QMSR Archives - Quality Hub

FDA Veteran: ‘My Thinking Has Evolved’ on Efforts by MedTechs to Comply With QMSR Rule

July 9, 2025

A 31-year FDA veteran and QualityHub VP, Sean Boyd, highlights that MedTech companies face significant challenges preparing for the FDA’s new Quality Management System Regulation

MedTech’s QMSR: FDA Says Live Training In Store For Investigators This Summer

May 1, 2025

The FDA is preparing for its new Quality Management System Regulation by training investigators on a new inspection model replacing the old QSIT method. This

FDA to MedTech Companies Waiting to Comply With New QMSR Rule: ‘Don’t Do That’

April 24, 2025

The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.