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Quality Management System Regulation
The FDA Quality Management System Regulation (QMSR) is a framework that aligns with global standards for regulating the quality management of medical devices. It integrates the FDA’s existing Quality System Regulation (QSR), outlined in 21 CFR Part 820, with international standards such as ISO 13485.
The FDA’s shift to QMSR is part of a modernization effort aimed at harmonizing U.S. regulations with international practices, simplifying compliance for medical device manufacturers selling products globally. This regulation defines the requirements for establishing and maintaining a quality system to ensure devices meet safety and efficacy requirements throughout their lifecycle—from design, and production, to post-market surveillance.
Key components of FDA QMSR are the following:
- Design Controls to establish medical device design to meet the user needs and intended uses.
- Systematically identifying and mitigating risks throughout the product lifecycle.
- Developing a proper Corrective and Preventive Actions (CAPA) system for addressing issues that could lead to product nonconformities.
- Monitoring and controlling manufacturing processes to ensure consistent device quality.
Medical device manufacturers currently operating under the FDA’s Quality System Regulation (QSR) will eventually need to transition to the updated Quality Management System Regulation. The transition is necessary because the FDA is aligning its regulatory framework with the international ISO 13485 standard for medical device quality management.
The deadline for QMSR compliance is officially set for February 2, 2026, manufacturers should use the time leading up to that date to ensure a smooth transition from QSR to QMSR. Preparing now will help avoid non-compliance risks when the new regulation comes into full effect.
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Need of US FDA QMSR Consultants
FDA QMSR Consultants can provide a fast-track approach to compliance, helping companies implement necessary changes more quickly and efficiently than possible using only internal resources. We’re working with firms small and large to assess, plan, and execute QMSR transition projects.
It’s worth enough to appoint FDA QMSR compliance consultants especially those with limited in-house regulatory expertise. There are several key reasons:
- Examine the existing 21 CFR 820 documentation and its level of implementation, then formulate a comprehensive plan for the transition to QMSR.
- Understand other market requirements such as Europe and Asia-pacific, and if required develop an integrated single documentation structure for ISO 13485 and QMSR
- Drafting all mandatory procedures, quality manuals, and standard forms for record creation.
- Process owner interaction and guidance
- Guidance on implementation and review of records and reports generated by the organization
- Training for Internal auditor qualification
- Internal audit support
- FDA post-inspection support
- Closing of 483’s
With the FDA QMSR compliance deadline approaching, the need to find the right regulatory professionals who can guide companies is increasing. I3CGLOBAL’s team of expert regulatory professionals and lead auditors, with extensive experience in ISO 13485 implementations worldwide, is well-prepared to navigate the FDA’s latest regulatory changes, ensuring compliance with ISO 13485 and QMSR requirements efficiently.
Know more about FDA QMSR
QMSR Vs QSR 21 CFR 820
The Quality System Management Review (QSMR) and the Quality System Regulation (QSR) are both related to quality management in regulated industries, such as medical devices, but they serve different purposes and are structured differently. Here are the key differences
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QSMR |
QSR |
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Scope and Application |
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Broadens the scope to include additional stakeholders like contract sterilizers and remanufacturers, aligning more closely with international standards. |
Applies mainly to medical devices marketed in the U.S., focusing specifically on manufacturing processes and quality assurance. |
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Regulatory Alignment |
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Seeks to harmonize U.S. regulations with global standards, particularly ISO 13485:2016, facilitating easier compliance for global market access. |
Follows older FDA-specific regulations, tailored primarily to U.S. requirements |
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Terminology and Definitions |
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Adopts international terminology from ISO 13485:2016, updating many traditional terms to align with global standards while maintaining the requirements under new terminologies. |
Utilizes FDA-specific terminology, including terms like DHF, DMR, and DHR |
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Documentation and Record Keeping |
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Emphasizes system-wide documentation and record-keeping in line with ISO 13485, incorporating broader criteria for maintaining and protecting records |
Focuses on detailed FDA-specific documentation requirements |
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Labelling and Packaging |
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Retains stringent FDA requirements but integrates ISO 13485 standards for labelling, with increased emphasis on verification and inspection processes by manufacturers |
Contains specific and detailed requirements for labelling and packaging to meet FDA standards |
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Risk Management |
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Places a stronger emphasis on integrating risk management throughout the device lifecycle, aligning with ISO 14971 standards (although compliance with ISO 14971 is not directly |
Primarily addresses risk management during design validation |
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Inspection and Compliance |
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Updates inspection methodologies to better align with ISO 13485, although specific changes are still being finalized |
Uses the FDA’s Quality System Inspection Technique (QSIT) for inspections |
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Certification and Compliance |
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Does not require ISO 13485 certification but encourages compliance to facilitate market access globally |
Requires compliance with FDA-specific regulatory standards |
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Implementation Timeline |
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Enacted in 2024 with a transition period ending in 2026, allowing organizations time to adjust to the new regulations |
Established with periodic updates over the years |
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Regulatory Priorities |
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Aims to reduce regulatory redundancies and simplify processes by aligning more closely with international standards, promoting a more unified approach to global market access |
Focuses on ensuring product |
QMSR is an internal review process aimed at evaluating and improving the effectiveness of an organization’s Quality Management System whereas QSR is a set of FDA-enforced regulations that medical device manufacturers must follow to ensure the safety and efficacy of their products in the U.S. market.
We are medical device regulatory professionals. Working with I3CGLOBAL enables manufacturers to upgrade their current QSR to QMSR more efficiently and quickly.
Frequently Asked Questions
Will the FDA issue a QMSR certificate to companies following an audit?
No, the FDA does not issue a Quality Management System Regulation (QMSR) certificate after an onsite audit. Instead, the FDA conducts inspections to verify compliance with standards.
After an onsite inspection, if any deficiencies are observed the FDA provides feedback through an FDA Form 483 or may issue a Warning Letter in case of significant non-compliance. However, they do not provide formal certification of compliance.
In contrast, other Certification Bodies like BSI, DNV, TUV, and SGS can issue certificates after ISO 13485 audits, which some companies may pursue in addition to meeting FDA QMSR requirements.
Can we apply for ISO 13485 certification concurrently with QMSR compliance?
Yes, a company can apply for ISO 13485 certification in parallel with the FDA QMSR, While both systems focus on ensuring the quality and safety of medical devices, they have distinct requirements. Integrating your quality management system with both ISO 13485 and QMSR can streamline regulatory audits and inspections, and also make single documentation.