QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026
- Ivana Loffa
- Aug 26
- 2 min read
Updated: Sep 8
Final Rule:
The FDA has finalized a major final rule to amend device current good manufacturing practice requirements of the Quality System Regulation (QSR) in 21 CFR Part 820. This is the first major revision of Part 820 since 1996. The agency issued its Quality Management System Regulation (QMSR) on January 31, 2024, and then published the final rule in the Federal Register on February 2, 2024. The rule is effective on February 2, 2026, giving manufacturers a two-year transition window to get their Quality Management Systems into compliance.
What this means for your company:
Comprehending the differences between the new FDA QMS Regulations and the old QSR is crucial for effective transition planning. Adding ISO 13485:2016 by reference is the biggest modification to the FDA QMSR. The FDA QMSR aligns U.S. rules with international norms, in contrast to QSR, which was based only on FDA-defined obligations. International manufacturers can now deploy uniform quality management systems in all markets because of the FDA's QMSR harmonization. Equally important, QMSR explicitly integrates ISO 14971 risk management principles through the addition of ISO 13485:2016, which marks a decisive shift toward a risk-based approach to quality system management.
To help illustrate exactly what has changed, we’ve put together the following side-by-side comparison table. It shows how QSR requirements map against QMSR updates, and highlights where risk management and ISO standards now take center stage.
How AltaQ can help:
AltaQ has extensive experience implementing Quality Systems under both QSR and ISO 13485. Our proven experience and regulatory expertise enable us to efficiently update existing quality systems and implement QMSR requirements, including the critical integration of ISO 14971 risk management requirements into design control processes. We understand the nuances of transitioning from traditional QSR-based systems to the harmonized QMSR framework, ensuring compliance while maintaining operational efficiency throughout the implementation process.
Our validation services encompass analytical validation, software verification, and facility qualification programs designed to demonstrate compliance with risk-based quality management requirements. Additionally, our EU IVDR expertise and CE marking capabilities enable manufacturers to leverage QMSR compliance for accelerated European market access, implementing unified quality systems that support both FDA and EU regulatory requirements while reducing long-term compliance costs through strategic harmonization.
There are only six months left before a changing inspection landscape. Now is the time to move from awareness to execution! Let’s talk: info@altaq.com