January 26, 2026

The Quality Management System Regulation (QMSR), published by the FDA in January 2024, amends 21 CFR Part 820, the primary rule governing the design, production, and control of medical devices in the United States. The alignment with ISO 13485:2016 enables manufacturers operating across multiple jurisdictions to maintain a single, integrated quality management system rather than separate systems for U.S. and international regulatory compliance. With the February 2, 2026 compliance deadline approaching, manufacturers that have not yet begun aligning their quality systems must act now to assess gaps, update processes, and ensure readiness before enforcement begins.

The regulatory landscape has changed over the past 20 years, as the FDA noted when proposing the QMSR. The FDA is harmonizing the old Quality System Regulation (QSR) with ISO 13485 to modernize U.S. medical device quality requirements and align them with current, globally accepted standards. While ISO 13485 has been updated multiple times to reflect evolving quality system expectations, the QSR has remained largely unchanged since its introduction in 1996. By incorporating ISO 13485 by reference, the FDA can formally adopt internationally recognized practices that are already followed in many global markets. The agency has closely monitored each revision of ISO 13485 and determined that the 2016 version closely aligns with the intent and structure of 21 CFR Part 820. Because ISO standards are regularly reviewed and ISO 13485:2016 remains unchanged till 2030, the FDA considers it a stable and appropriate foundation for U.S. medical device quality regulation.

Additionally, the FDA highlights in the Final Rule that the QSR and ISO 13485 quality system criteria are already rather similar, thus the shift should not significantly raise firms’ compliance burden. Rather, harmonization is meant to streamline regulatory requirements, cut down on unnecessary paperwork and audits, and promote worldwide uniformity across device markets. The FDA anticipates that by adhering to an international standard, producers will encounter fewer conflicting regulations and patients will have more effective access to high-quality, safe medical equipment.

The primary distinction between the new Quality Management System Regulation (QMSR) and the previous Quality System Regulation (QSR) is that the FDA now explicitly incorporates ISO 13485:2016 into 21 CFR Part 820. This implies that many QSR requirements have been fulfilled by simply adhering to the relevant ISO requirements. As a result, requirement terms like Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR) have been eliminated from QMSR. The more general Medical Device File (MDF) concept of ISO 13485 takes the place of these eliminated concepts, which are still in place. To maintain uniformity with the U.S. regulatory framework, FDA definitions will take precedence over ISO standards in cases where they clash with FDA laws, such as when defining “device” or “labeling.”

Additionally, QMSR strengthens the labeling and packaging section (§820.45) and adds a number of new parts to Part 820, such as revised record management requirements. The FDA introduced this section because ISO 13485’s fundamental requirement was not adequately stated, and many device recalls are the result of labeling and packing problems. Companies are required by QMSR to have explicit procedures that outline the inspection, storage, handling, and control of labeling and packaging, including details like UDI/UPC, expiration dates, and storage or handling guidelines. Manufacturers should begin assessing labeling and packaging well in advance of the February 2026 compliance deadline because these new criteria complement the current regulations in 21 CFR Part 801.

A company’s present quality system will determine how QMSR affects it. There won’t be many significant changes for manufacturers who are already ISO 13485:2016 certified or closely matched. The majority of their effort will be revising protocols to make reference to QMSR, eliminating obsolete QSR terminology, and making minor modifications to guarantee complete compliance. The transition to QMSR is anticipated to lessen the complexity and expense of maintaining distinct systems for FDA and overseas markets because these businesses operate under a framework already recognized in significant markets like the EU, Canada, Australia, and Japan.

Companies that are not in line with ISO 13485 and have been using the 21 CFR Part 820 QSR, on the other hand, will be significantly affected. To comply with ISO-based requirements, these companies will have to update a number of processes, documents, and forms, particularly in areas like risk management, where QMSR emphasizes risk-based decision-making throughout the device lifecycle. Meeting these criteria will involve implementing ISO 14971 for risk management procedures. Additionally, the rule modifies Part 4 for combination goods by substituting ISO 13485 clauses for outdated QSR references. In order to update their quality systems and get ready for inspections, producers should thoroughly review the QMSR framework

A comprehensive gap assessment comparing their current QSR-based quality system to ISO 13485 and the new QMSR requirements should be the first step for manufacturers getting ready for the 2026 QMSR compliance deadline. This assessment will assist in identifying areas that require updating, including recordkeeping processes, supplier controls, risk management protocols, and documentation structure. Companies will need to update many aspects of their quality system to meet ISO terminology and QMSR standards because the change affects SOPs, work instructions, templates, and inspection preparedness tools. Because ISO 13485 mandates that leadership actively participate in quality planning, resource allocation, and continuing system assessments, management involvement is also crucial.

Manufacturers must update documents and train staff members on how QMSR affects their day-to-day business. Companies should anticipate that QMSR-based audits would differ from previous QSR inspections since the FDA is upgrading its inspection methodology and educating inspectors. An essential last step is to update internal audit systems to assess compliance with both ISO 13485 and the FDA-specific components of QMSR. Practicing under the new system will assist in guaranteeing that the company can run successfully under the revised regulatory framework and confidently demonstrate compliance during FDA inspections.

With the implementation of the QMSR, medical device quality systems regulations in the US will undergo significant change, aligning FDA requirements with globally accepted standards like ISO 13485:2016. All manufacturers must take the time to comprehend the new framework, examine their processes, and update their paperwork in order to achieve the February 2, 2026, compliance deadline, even if the transition will be simpler for businesses already in conformity with ISO norms. Manufacturers may increase the likelihood of a seamless transition and set themselves up for more effective compliance in both domestic and international markets by planning ahead, bolstering risk-based procedures, and coordinating labeling, packaging, and record-keeping procedures with QMSR requirements.

Anand Bhati

Regulatory Specialist

Anand Bhati is a Regulatory Specialist at Accorto Regulatory Solutions with experience in regulatory submissions, risk management, and global compliance for medical devices. He holds a Master’s in Regulatory Affairs from Northeastern University. His experience includes supporting 510(k) submissions, risk assessments, and regulatory strategy development for medical devices. He has contributed to post-market surveillance initiatives, clinical compliance tools, and vigilance reporting, ensuring adherence to FDA and international regulations. With a strong focus on cGMP compliance and quality systems, Anand is committed to regulatory excellence and facilitating market access for healthcare innovations.

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2. Center for Devices and Radiological Health. (n.d.-b). Quality Management System Regulation: Final rule – FAQ. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

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