QMSR 2026: Ensure FDA and ISO 13485 Compliance with GxpManager ECMS

With less than a year to go, anticipate FDA requirements, align your quality processes with ISO 13485, and discover how GxpManager ECMS can safeguard your global compliance.

Audits, CAPA, Medical devices, QMSR, quality, Risk Management

Starting February 2, 2026, the FDA will enforce the Quality Management System Regulation (QMSR), a complete overhaul of the current Quality System Regulation (QSR). This major change reflects a clear commitment to international harmonization: the QMSR adopts ISO 13485:2016 as its regulatory foundation, already in effect since February 2019.

The goal of this transition is to simplify compliance for manufacturers operating across multiple markets while modernizing the U.S. regulatory framework. It clarifies FDA expectations and strengthens the focus on risk management, quality documentation, and product traceability.

What is changing in practical terms?

Incorporation by Reference of ISO 13485:2016

The QMSR introduces a major regulatory shift by directly incorporating ISO 13485:2016, along with Clause 3 of ISO 9000:2015 for definitions, into the legal framework of 21 CFR Part 820. This approach facilitates the harmonization of key practices such as risk management, documentation, and internal audits.

However, certain U.S.-specific requirements remain. For example, the ‘device history file’ becomes the ‘medical device file’ under FDA terminology. In the event of a conflict between the ISO standard and U.S. regulations, FDA definitions take precedence.

New Chapters of Part 820

The QMSR introduces several new structural sections:

Section 820.7 establishes the incorporation by reference of ISO standards.
Section 820.10 specifies the general requirements of the quality system.
Section 820.35 governs record control.
Section 820.45 covers labeling and packaging, including UDI, expiration date, and storage instructions

The GxpManager platform natively meets these new regulatory requirements. Its modules for quality management, audits, labelling, packaging, and supplier oversight have been designed to fully comply with QMSR expectations.

New Controls

The FDA is adopting an inspection approach aligned with ISO 13485, ending the exceptions that previously applied to internal audits. From now on, management reviews, quality audits, and supplier evaluations must be fully accessible to inspectors.

These reinforced requirements mean that companies must have reliable and secure tools (such as GxpManager) to ensure rapid and controlled access to quality documents and data—particularly for internal and supplier audits.

Opportunities & Challenges

Opportunities	Challenges	GxpManager - Solution	undefined
Global alignment = reduced regulatory effort and rework	Heavy workload of document updates and internal processes	✅ Centralized management of quality documentation ✅ Digitalization of forms ✅ Process automation …to streamline collaboration and leverage data in full compliance	GxpQMS module
Improved risk management, traceability, labeling	New formalities: UDI, labeling, packaging	Risk management modules with native traceability, and integration of the Artworks suite to efficiently manage: ✅ UDI ✅ Packaging data ✅ Validation cycles up to final artwork approval ✅ Integrated quality control ✅ Cross-functional collaboration on a single platform	Artworks module
More consistent and structured inspections	More in-depth inspection of internal audits, removal of exceptions	Comprehensive audit modules to meet FDA and ISO requirements: ✅ Time-stamped audit trail ✅ Secure access management for reviews ✅ Key reports and records	Audit Management module

GxpManager ECMS: International Compliance

With less than a year before QMSR comes into effect, medical device manufacturers must prepare for a profound overhaul of their quality systems. This transition to ISO 13485:2016 is far more than a documentation update: it requires a strategic revision of internal processes, risk management, audits, and supplier oversight.

GxpManager ECMS (Enterprise Compliance Management System) serves as an operational and digital lever to navigate this transition methodically. Its pre-validated platform, compliant with QSR, QMSR, and ISO 13485 requirements, enables complete and secure quality management: data traceability, audit trail, documentation, risk, audits, and suppliers

The transition to QMSR is not just a regulatory update—it is an opportunity for global quality transformation. By leveraging a platform like GxpManager and its ECMS application, companies can effectively meet FDA requirements while optimizing overall performance. Compliance thus becomes a lever for lasting competitiveness in international markets.

The transition to QMSR is not just a regulatory requirement—it is an opportunity to modernize your quality system and strengthen your international competitiveness.

With GxpManager ECMS, you gain access to a pre-validated platform with a modular and scalable architecture, perfectly suited to QMSR challenges:

Structure your compliance according to FDA and ISO 13485 requirements,
Centralize your quality processes, audits, risks, and suppliers,
Digitize your documents and forms securely,
Support the continuous evolution of your quality system without disruption or complexity.