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QEBX Blog

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A Strategic Guide to the FDA's New Quality Management System Regulation (QMSR)

By Deanna Paulsen • December 2, 2025
The new FDA QMSR (2/2/26) replaces QSR, adopting an ISO 13485-plus model, standardizes lexicon (DHF/DMR/DHR eliminated), and removes record exemptions for internal/supplier audits.

Sterigenics Expands with New X-Ray Facility

By Deanna Paulsen • June 11, 2025
Exciting News in Sterilization

Auditor's Perspective: ISO 13485 QMS Requirements

By Adriana Uranga • May 3, 2024
The Framework for a Successful Operation: ISO 13485: Section 4, Quality Management System

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