The US Food and Drug Administration (FDA) is entering the final phase of one of the most significant regulatory transitions for medical devices in decades. After years of discussion, public consultation, and alignment efforts, the FDA has confirmed that its long-standing Quality System Regulation (QSR) will be replaced by the Quality Management System Regulation (QMSR). This shift formally harmonizes US quality requirements with ISO 13485:2016, the global cornerstone standard for medical device quality management.
For many manufacturers—particularly those active in global markets—this transition is not a surprise. The industry has been anticipating this move for several years, and many organizations have already begun aligning their quality systems with ISO 13485. At QNET, we support numerous clients worldwide in adopting or strengthening ISO 13485-based quality systems, including United Sports Brands (USB), whose QMS is already structured in accordance with ISO 13485:2016.
With QMSR, international alignment will increase, regulatory overlap will decrease, and manufacturers will benefit from a more consistent and predictable global compliance pathway.
Background: From QSR to QMSR
1. QSR Origins (1996)
Since 1996, US medical device manufacturers have been required to comply with 21 CFR Part 820, commonly known as the Quality System Regulation.
The regulation established Good Manufacturing Practice (GMP) requirements to ensure safety and effectiveness during design, production, packaging, labeling, storage, and servicing.
2. FDA Publishes the Final Rule (2024)
On 2 February 2024, the FDA published the final rule titled “Medical Devices; Quality System Regulation Amendments” in the Federal Register.
The rule implements two major changes:
- Renaming QSR → QMSR (Quality Management System Regulation)
- Harmonization with international QMS requirements, specifically ISO 13485:2016
Through incorporation by reference, the FDA formally adopts:
- ISO 13485:2016 – Quality management systems for medical devices
- ISO 9000:2015, Clause 3 – Terms and definitions
3. FDA Draft Guidance on Submissions (2025)
On 27 October 2025, the FDA released draft guidance describing the QMS-related information expected in new submissions, including:
- DUNS numbers for all manufacturing sites
- A UDI assignment and maintenance plan
- A clear mapping of QMS processes to ISO 13485 clauses
- Clarified expectations for PMA and HDE submissions under QMSR
This draft marks a shift away from the US-centric legacy QSR approach toward a globally harmonized, risk-based framework.
4. Effective Date
The QMSR becomes fully effective on 2 February 2026, replacing the existing QSR through amendments to 21 CFR Part 820. From that date onward, ISO 13485 compliance is no longer only “helpful”—it becomes the foundational requirement for all US medical device manufacturers.
What This Means for Manufacturers
Global Alignment and Reduced Regulatory Burden
With ISO 13485 at the core of US quality requirements, manufacturers operating in Europe, the UK, Switzerland, and other ISO-aligned markets will benefit from streamlined compliance and less duplication.
More Predictable Inspections
FDA investigators will evaluate quality systems using ISO-aligned terminology and structure. Organizations already operating under ISO 13485 will recognize most requirements, though the FDA retains certain US-specific expectations, including complaint handling, CAPA, and reporting obligations.
Updated Submission Requirements
Risk management, UDI strategy, and organizational traceability (including DUNS number accuracy) will now be integral parts of PMA and HDE submissions.
Stronger Emphasis on Risk-Based Processes
Like ISO 13485, QMSR reinforces a lifecycle approach, integrating risk management into design, manufacturing, and post-market activities.
How QNET Supports Clients During the QMSR Transition
QNET is already working with manufacturers preparing for the February 2026 enforcement date. Our support includes:
- Gap assessments between existing QSR-based systems and ISO 13485:2016
- Implementation or upgrading of ISO 13485-aligned QMS structures
- Documentation mapping for FDA submissions under the draft guidance
- PMS, vigilance, and UDI strategy development
- Internal audits conforming to ISO 13485, FDA expectations, and global AR/UKRP/CH-REP requirements
Because QNET operates across the EU, UK, Switzerland, and the US, clients benefit from unified guidance that addresses both US and international regulatory expectations.
Conclusion
The FDA’s shift from QSR to QMSR marks a historic milestone in international regulatory alignment. With ISO 13485 at the center of the new rule, manufacturers will face a more consistent global framework—one that supports quality, innovation, and patient safety. Organizations that have already adopted ISO 13485 are well-positioned for the transition, while others will need to begin preparing now to meet the February 2026 deadline.
QNET will continue to follow developments closely and provide further updates and practical guidance to our clients in the coming months.