About this Site

About QSR-to-QMSR

The U.S. medical device regulatory landscape is undergoing one of its most significant changes in decades. With the adoption of the Quality Management System Regulation (QMSR), the U.S. Food and Drug Administration (FDA) has aligned its device quality system requirements with ISO 13485:2016, the international standard for medical device quality management systems.

The transition from the former Quality System Regulation (QSR) to the QMSR represents more than a simple regulatory update. It reflects a broader shift toward internationally harmonized quality systems, risk-based decision making, and lifecycle management of medical devices.

QSR-to-QMSR.com was created to help regulatory professionals, quality leaders, and device manufacturers understand and navigate this transition.

The Purpose of This Site

The goal of this site is to provide clear, practical information about the transition from QSR to QMSR and what it means for companies operating in the U.S. medical device market.

Initially, the focus of this site was to explain the structure and intent of the QMSR rule and help manufacturers understand how the FDA’s regulatory framework now incorporates ISO 13485.

However, the implementation of the QMSR is only the beginning.

As the new regulation becomes operational, manufacturers must interpret and apply the requirements in real-world quality systems, design programs, supplier controls, and postmarket activities. For many organizations, the challenge now lies in translating regulatory language into effective operational practices.

Moving Beyond the Rule

Now that QMSR is in place, QSR-to-QMSR.com is evolving into a broader resource focused on the practical implementation of the new regulatory framework.

Ongoing content will explore key topics of risk management, design and development controls, supplier qualification and oversight, complaint handling, postmarket surveillance, CAPA systems, internal audits, and FDA inspection readiness.

Our objective is to provide insight into how these requirements function in practice, not just how they appear in regulatory text.

Who This Resource Is For

This site is intended for professionals working in or alongside the medical device industry, including regulatory affairs professionals, quality assurance leaders, medical device manufacturers, consultants and auditors, engineers involved in device development, and students and professionals interested in regulatory science.

Whether you are responsible for implementing a quality system, preparing for an FDA inspection, or simply trying to understand how U.S. device regulation is evolving, this site is designed to provide accessible and practical information.