As the life sciences industry evolves, regulatory bodies like the U.S. Food and Drug Administration (FDA) continue to refine standards to ensure patient safety, product efficacy, and global harmonization. One significant update is the Quality Management System Regulation (QMSR), set to take effect on February 2, 2026. This new rule amends the longstanding Quality System Regulation (QSR) under 21 CFR Part 820, aligning it more closely with international standards. For manufacturers of medical devices and related life science products, preparing for this transition is essential to avoid disruptions, maintain compliance, and leverage opportunities for improved quality processes.

What are the Key Changes from QSR to QMSR?

While the QMSR builds on the QSR, several notable differences will impact how manufacturers operate. Here’s a breakdown of the most critical updates:

1. Incorporation of ISO 13485:2016

The core of the QMSR is the direct adoption of ISO 13485:2016 requirements. This standard emphasizes a process-based approach to quality management, focusing on customer satisfaction, continual improvement, and risk management throughout the product lifecycle. Unlike the QSR, which was more prescriptive, ISO 13485 is more flexible, allowing manufacturers to tailor systems to their specific risks and operations.

2. Enhanced Risk Management Integration

One of the most prominent changes is the explicit integration of risk management across all quality processes. Under the QMSR, manufacturers must incorporate risk-based decision-making into areas like design controls, purchasing, and corrective actions. This aligns with ISO 14971 (the standard for risk management in medical devices) and goes beyond the QSR’s more limited focus on design and production risks. For example, risk assessments will now influence supplier evaluations and process validations more comprehensively.

3. Updated Terminology and Definitions

The QMSR adopts ISO terminology, such as replacing “management responsibility” with “top management responsibility” and “device master record” with “medical device file.” It also incorporates definitions from Clause 3 of ISO 9000:2015 for consistency. Manufacturers will need to revise documentation to reflect these terms, ensuring no confusion during audits or inspections.

4. FDA-Specific Additions

Not all aspects are purely ISO-based. The FDA retains authority over certain elements, including:

• Controls for labeling and packaging to prevent mix-ups.
• Requirements for unique device identification (UDI) compliance.
• Traceability for implantable devices.
• Record-keeping aligned with FDA’s broader regulations.

These additions ensure the QMSR complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

5. Inspection and Compliance Adjustments

The FDA plans to update its inspection processes, documented in a revised Compliance Program (CP) for medical device manufacturers. Inspections will evaluate compliance with the QMSR, including ISO 13485 elements. Until February 2, 2026, the QSR remains in effect, but manufacturers should anticipate a transitional period where both may apply in certain contexts.

For manufacturers already certified to ISO 13485, the transition may involve minimal changes, primarily addressing FDA-specific requirements. However, those solely compliant with the QSR could face more substantial updates.

Steps for Life Science Manufacturers to Prepare

Manufacturers should adopt a proactive, phased approach to compliance. Here are some suggested steps to help prepare organizations:

Step 1: Conduct a Gap Analysis

Begin by comparing your current QMS against ISO 13485:2016 and the QMSR’s additional requirements. Identify discrepancies in areas like risk management, supplier controls, and documentation. Tools like checklists from ISO or FDA resources can help. Engage internal teams or third-party consultants for an objective review. And when it comes to documenting the results of that review, using a robust eQMS like AssurX allows for a centralized location to log gaps, owners, due dates, and evidence of successful closure.

Step 2: Update Policies and Procedures

Revise your quality manual, standard operating procedures (SOPs), and work instructions to incorporate ISO 13485 elements. Focus on integrating risk management into all processes, from design input to post-market surveillance. Ensure top management is involved in defining quality objectives and reviewing system performance, and that those updates are appropriately completed and documented. Our Document Management solution can help with this by facilitating the routing of document changes for review and approval, managing effective dates, and ensuring that only the most current procedures are in use.

Step 3: Enhance Risk Management Practices

If not already in place, implement a robust risk management framework per ISO 14971. Train staff on risk assessment tools like failure mode and effects analysis (FMEA) and ensure risks are considered in decision-making across the organization. Using AssurX can help standardize those FMEA/risk workflows, maintain version control, and even help link identified risks to design controls, CAPA, and change management.

Step 4: Train Employees and Build Awareness

Compliance requires buy-in at all levels. Develop training programs on the QMSR, ISO 13485, and any new procedures. This is particularly important for quality assurance, regulatory affairs, and manufacturing teams. Consider certification courses for key personnel to deepen expertise. As these tasks are completed, ensure appropriate documentation through the use of eQMS systems like AssurX. Our Training Management solution can help assign, track, and document training completion.

Step 5: Audit and Validate Systems

Perform internal audits to test your updated QMS. If applicable, seek third-party certification to ISO 13485 ahead of the deadline; this can serve as evidence of readiness during FDA inspections. Validate processes, especially those involving software or automated systems, to ensure they meet the new risk-based criteria. Better yet, automate this process by using our Audit Management solution, which supports all audit types (including internal audits), along with finding follow-ups and robust documentation to support verification and validation activities.

Step 6: Review Supplier and Partner Agreements

Evaluate suppliers against the QMSR’s risk-based purchasing controls. Update contracts to require ISO 13485 compliance where relevant and conduct supplier audits as needed. AssurX can help – using our Supplier Quality Management solution, users can manage supplier qualification, monitoring, audits, SCARs, and more.

Step 7: Prepare for FDA Interactions

Monitor FDA guidance, such as the draft on QMS information for premarket submissions issued in October 2025. For ongoing submissions or inspections, be ready to demonstrate transitional compliance. AssurX can help maintain inspection-ready documentation and evidence, allowing teams to respond quickly and consistently to FDA requests. Additionally, the FDA has indicated it will provide webinars and resources to support the transition.

Timeline and Compliance Considerations

• Now through Mid-2025: Focus on gap analysis and planning.
• Mid-2025 to January 2026: Implement updates, train staff, and conduct audits.
• February 2, 2026: Full compliance required. The FDA will enforce the QMSR in inspections thereafter.

Non-compliance could result in warning letters, product holds, or recalls. However, early preparation can turn this into an opportunity for efficiency gains and competitive advantage.

The Benefits of Strategic Planning for QMSR Now

The QMSR represents a forward-thinking shift toward global harmonization, emphasizing risk management and flexibility in quality systems. For life science manufacturers, the key to success lies in early preparation—starting with a thorough gap analysis and extending to comprehensive training and system updates. By aligning with ISO 13485 and FDA specifics, companies can not only meet regulatory demands but also enhance product quality and market access. And using a comprehensive eQMS like AssurX supports this type of risk-based transformation by connecting documents, training, audits, suppliers, risk, and CAPA into a single, traceable system. With strategic planning and the use of supportive resources, such as an eQMS, this transition can strengthen your organization’s foundation for long-term innovation and safety.

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About the Author

Stephanie Ojeda is Vice President of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 18 years of experience leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.