Read our expert insights on responding to the FDA’s regulatory update and aligning with ISO 13485 by 2026.
Understanding the FDA’s Requirements and ISO 13485 Alignment
In 2024, the U.S. Food and Drug Administration (FDA) introduced new quality system requirements for medical devices—the most significant change in over 25 years.
These new requirements, called the Quality Management System Regulation (QMSR), replace the previous Quality System Regulation (QSR) and bring U.S. expectations in line with ISO 13485:2016, the globally recognized standard for medical device quality management.
The Goal?
To simplify regulatory compliance, improve inspection efficiency, and support international market access. With the rule set to take effect in February 2026, medical device manufacturers should begin preparing their systems, teams and documentation now.
Why the FDA Is Aligning With ISO 13485
The QMSR brings U.S. regulation in line with ISO 13485:2016—with key FDA-specific additions. The update supports four key objectives:
- Global consistency: ISO 13485 is already accepted or required in the EU, Canada, Australia, Japan and other major markets. Aligning with this standard makes it easier for U.S. companies to operate internationally without managing multiple systems.
- Simplified compliance: A unified approach reduces the need for region-specific documentation and processes, supporting a more coordinated approach to quality system management.
- Leveraging existing systems: Many U.S. manufacturers already hold ISO 13485 certification. The QMSR allows them to use this as a basis for meeting both FDA and global requirements more efficiently.
- Streamlined auditing: The QMSR moves the U.S. closer to the Medical Device Single Audit Program (MDSAP), which can allow a single audit to meet the needs of multiple regulators.
These shifts reflect the FDA’s aim to modernize its oversight and support a globally integrated medical device sector.
What the FDA QMSR Means for U.S. Medical Device Manufacturers
If your organization already complies with the FDA’s QSR (21 CFR Part 820), many of the principles within ISO 13485 will be familiar.
However, the updated regulations introduce differences in structure, terminology, and the emphasis placed on risk management and lifecycle control. These changes may require meaningful updates to your quality management system and processes, to meet the FDA-specific requirements.
Key focus areas could include:
- Risk management: Proactive risk oversight is expected throughout the entire product lifecycle, not just during product design. ISO 13485 requires this risk-based approach to be embedded across all quality management system processes.
- Design controls: Greater traceability, formal validation procedures, and comprehensive documentation are required to demonstrate that design outputs meet defined requirements.
- Supplier oversight: Manufacturers must implement formal procedures for evaluating, qualifying, and monitoring suppliers and third-party providers. This supports product quality and regulatory accountability throughout the supply chain.
- Complaint handling and post-market activities: Structured processes are required for investigating complaints, conducting post-market surveillance, and initiating corrective actions—as outlined in ISO 13485.
These updates reflect international best practices and help support safer, more consistent manufacturing. Addressing them early can also support regulatory preparedness and improve readiness for FDA inspections or global audits.
Why ISO 13485 Certification Matters Under the QMSR
While ISO 13485 certification is not mandatory under the QMSR, it is encouraged, as it can help demonstrate conformance and offers recognized benefits across quality, credibility, and market access.
For organizations not yet certified, now is the right time to consider beginning the process.
Certification to ISO 13485:2016 offers:
- Assurance that your organization has implemented a robust medical device quality management system that meets the requirements set in the standard and aligns with updated FDA expectations.
- Greater confidence in audit readiness and outcomes.
- Credibility with global partners, regulators and buyers.
- Support for entry into regulated markets including the EU and Canada.
Early action can also help reduce the complexity of the QMSR transition by ensuring that your systems are aligned with the standard the FDA is now using as its reference point.
How Amtivo Can Support Your QMSR and ISO 13485 Transition
The FDA’s move toward ISO 13485 marks a major step in the modernization of U.S. medical device regulation. It reflects a broader shift toward globally aligned quality management systems—and a chance for manufacturers to position themselves for potential competitive advantage through improved process control, assurance and scalability.
Whether you are starting from scratch or adapting an existing system, Amtivo provides trusted, accredited certification services to ISO 13485.
Ready to pursue ISO 13485 certification? Explore our accredited certification process here or contact us to discuss audit scheduling and certification requirements.
Explore more about ISO 13485 here or contact us to discuss certification.
