QMSR replaces QSR: What medical device manufacturers need to know now
From February 2, 2026, a new regulatory framework for quality systems will apply in the USA: The previous Quality System Regulation (QSR) will be officially replaced by the Quality Management System Regulation (QMSR). With this step, the US FDA is fully aligning itself with an international standard for the first time - ISO 13485:2016.
But what does this mean in concrete terms for manufacturers of medical devices, especially for companies with international markets? And why is ISO 13485 certification alone not enough?
This blog post provides an overview of the most important changes - and shows how MEDAGENT can help you implement them.
Overview: What is the QMSR?
The QMSR is the new quality management regulation of the US Food and Drug Administration (FDA) and replaces the previous QSR (21 CFR Part 820). The aim is to achieve greater international harmonization - particularly with the ISO 13485:2016 standard, which is already established worldwide. This will make it easier for international manufacturers to access the US market - albeit with restrictions.
The FDA remains true to its role as a regulatory authority: ISO 13485 certification does not replace an FDA inspection. Manufacturers must therefore continue to expect audits - and at the same time adapt their processes to the new requirements.
The most important changes at a glance
ISO 13485 as a basis
The QMSR is largely based on ISO 13485:2016. Anyone already working according to this standard has a good basis - but must take additional requirements from US law into account.
Terminology adjustment
Terms such as DHF (Design History File), DMR (Device Master Record) and DHR (Device History Record) are replaced by the internationally more common term Medical Device File (MDF).
Risk management in accordance with ISO 14971
The FDA expressly recommends integrating risk management systems in accordance with ISO 14971. Companies must not only systematically identify risks, but also document and monitor them continuously.
Extended documentation requirements
Among other things, new requirements must be observed in the following areas:
UDI (Unique Device Identification)
Traceability
Complaint handling and corrective actions
CAPA processes (Corrective and Preventive Actions)
No exceptions for inspections
Even if a company is certified according to ISO 13485, it remains fully accountable to FDA inspections. Certificates are not considered automatic proof of compliance.
Why the changeover is important
Advantages for manufacturers:
Less double regulation: A standardized system reduces the workload for companies with multiple market access points.
Clearer requirements: The QMSR creates transparency by aligning with established international standards.
More efficient processes: Those who work in compliance with ISO 13485 can also meet FDA requirements with less effort - provided the gaps are closed.
At the same time, the QMSR also means stricter requirements for implementation and verification. The FDA is currently planning to revise over 1,500 internal guidelines in order to introduce the QMSR - including new guidelines, forms and audit structures.
What you should do now
The time until 2026 may seem long - but in practice it is short. After all, a complete conversion of your QM system, the training of all employees and the updating of your documentation takes time.
We recommend the following steps:
Start gap analysis: What are the differences between your current ISO 13485 certification and the requirements of the QMSR?
Adapt documents and processes: Update your SOPs, risk management plans and CAPA processes.
Train employees and suppliers: Ensure a uniform understanding of the new requirements.
Know and implement FDA requirements: Also think about US-specific points such as UDI, labeling or complaint handling.
How MEDAGENT supports you
As experienced regulatory affairs experts, MEDAGENT supports you in adapting your processes to the QMSR efficiently and at an early stage - with a comprehensive service package:
Carrying out gap analyses between QSR, ISO 13485 and QMSR
Adaptation of your QM documentation including terminology and FDA-specific verification requirements
Audit preparation and support during FDA inspections
Training for teams and suppliers
Strategy consulting for global markets, taking into account MDSAP and multi-market strategies
Conclusion
The introduction of the QMSR marks a significant turning point for medical device manufacturers with a connection to the US market. While alignment with ISO 13485 is a relief, it is by no means a replacement for FDA regulatory requirements. Early preparation is crucial to avoid delays, inspection risks or barriers to market access.
MEDAGENT is at your side as a reliable partner to ensure that your changeover to QMSR is a success - competently, efficiently and reliably.
Contact us now and arrange a consultation.
