Preparing for the FDA’s QMSR: Your Guide to Compliance Success

Compliance & Regulation

Preparing for the FDA’s QMSR: Your Guide to Compliance Success

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Preparing for the FDA’s QMSR: Your Guide to Compliance Success

Preparing for the FDA’s QMSR: Your Guide to Compliance Success

“The only constant in life is change.” Those words, often attributed to the Greek philosopher Heraclitus, seem especially true in the medical device industry. Industry veterans have experienced a constant evolution of the regulations over the past 10 years. There was the update to ISO 13485 in 2016, the new EU MDR in 2017, changes to ISO 14971 in 2019, and now it’s the FDA’s turn.

In a long anticipated move toward global harmonization, the FDA has finalized its transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR). This shift, effective February 2, 2026, marks a significant evolution in how medical device manufacturers will be regulated in the U.S. As with any regulatory change, it presents challenges, but also provides opportunities for companies to become more efficient and stand out amongst their peers.

Whether you’re a startup building your first quality system or an established manufacturer already certified to ISO 13485, understanding the nuances of QMSR and creating a robust plan can help you not only stay compliant but also build a stronger, more competitive organization.

What is the QMSR?: A New Era in FDA Compliance

The QMSR is the FDA’s updated framework for medical device quality systems. It replaces 21 CFR Part 820 (QSR) and incorporates ISO 13485:2016 by reference as the foundational standard for compliance.

This alignment is designed to:

  • Harmonize U.S. regulations with international standards.
  • Reduce regulatory burdens for global manufacturers.
  • Promote faster access to safe, effective, high-quality devices.

Along with the major structural shift of incorporating ISO 13485, here are some other differences between the QSR and QMSR:

  • Terminology Updates: QMSR replaces legacy terms like “Device Master Record” with ISO equivalents such as “Medical Device File.”
  • Risk Management: QMSR emphasizes risk-based thinking throughout the product lifecycle, whereas QSR limited risk management to design validation.
  • Record Accessibility: QMSR mandates that internal records (e.g., management reviews, audits) be available for FDA inspection even though they were previously exempt under QSR.
  • Supplier Controls: QMSR requires documented supplier qualification and performance monitoring, enhancing QSR’s basic evaluation standards.
  • CAPA Enhancements: QMSR strengthens corrective and preventive action systems with trend analysis and effectiveness verification.
  • FDA-Specific Supplements: QMSR includes additional requirements to ensure consistency with the FD&C Act, such as complaint handling and UDI compliance.

RELATED: INBRAIN Chooses Jama Connect® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development

How QMSR Compares to ISO 13485

Since ISO 13485 provides the foundation of the new QMSR, companies that are ISO 13485 certified, or on their way to implementing it, will find themselves in a good position when transitioning.

However, the QMSR isn’t simply ISO 13485 renamed. While the two are 90–95% aligned, QMSR introduces FDA-specific requirements that companies will need to look out for when creating a plan to comply. It is also important to note that FDA definitions take precedence over ISO terms in case of conflict.

For a detailed breakdown of the new QMSR and how it compares to ISO 13485, check out this webinar, QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485. In the meantime, here is a quick rundown of the similarities and differences:

Key Similarities:

  • Risk-Based Thinking: Both emphasize integrating risk management throughout the product lifecycle.
  • Process Validation: Strong focus on validating critical processes and software.
  • Supplier Controls: Requirements for evaluating and managing suppliers.
  • Management Responsibility: Top management must foster a culture of quality.

Key Differences:

  • Terminology Adjustments: QMSR removes some terms like DHF, DHR, and DMR, but retains FDA definitions for terms like “device” and “labeling”
  • Expanded Traceability: ISO 13485 focuses on implantables; QMSR extends traceability to devices that sustain or support life
  • Labeling and Packaging Controls: QMSR introduces detailed requirements under §820.45, going beyond ISO’s general guidance
  • Recordkeeping and Accessibility: QMSR adds signature/date requirements and mandates that records be readily available for FDA inspection, even if stored offsite
  • FDA Inspection Scope: ISO certification doesn’t exempt companies from FDA inspections. QMSR maintains FDA’s authority and introduces broader inspection access

RELATED: Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage

Preparation Strategies for Different Company Types

If You’re a New Company Building Your First QMS

Start with Risk-Based Thinking

Implement integrated risk management from day one of your product development lifecycle. This means considering risk at every stage, from initial concept through post-market activities. Your QMS should demonstrate how risk management influences design decisions, manufacturing processes, and post-market surveillance activities.

Establish Clear Documentation Practices

Create documentation systems that scale with your organization. Digital platforms that provide traceability, version control, and automated workflows will serve you better than paper-based systems as you grow. Consider how your documentation will support FDA inspections and ensure all required records are easily accessible.

Build Culture of Quality Early

Establish quality-focused culture from your company’s foundation. This means training all employees on quality principles, establishing clear quality objectives, and ensuring leadership demonstrates commitment to quality in both words and actions.

For Established Companies with ISO 13485 Compliance

Conduct Comprehensive Gap Analysis

Review your current ISO 13485 implementation against QMSR-specific requirements. Pay particular attention to areas where the FDA has added clarifications or additional requirements beyond the standard.

Update Training Programs

Ensure your team understands both ISO 13485 requirements and FDA-specific additions. This includes understanding how the FDA interprets certain requirements and what inspectors will look for during assessments.

Enhance Documentation Traceability

While ISO 13485 requires traceability, FDA expectations around documentation completeness and accessibility are particularly stringent. Ensure your systems can demonstrate clear linkages between requirements, design outputs, verification activities, and post-market data.

For All Companies

Don’t Wait to Create a Transition Plan

The FDA’s QMSR transition deadline is February 2, 2026, and companies that delay preparation risk falling out of compliance. Starting early allows time to conduct gap analyses, update documentation, and train teams without the pressure of looming deadlines.

Engage with Industry Experts

Consulting firms with regulatory expertise can help identify areas where your current quality system may not meet QMSR requirements. They can also conduct mock audits and provide targeted training to ensure your team is inspection-ready.

Monitor FDA Updates

The FDA is actively revising its inspection protocols and guidance documents to reflect the new QMSR framework. Staying informed about these updates ensures your compliance strategy remains aligned with the latest regulatory expectations.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

How Jama Connect® Facilitates QMSR Transition

Navigating the new QMSR requires robust systems that support traceability, collaboration, and documentation throughout your product development lifecycle. Jama Connect provides the digital foundation necessary for successful QMSR implementation and long-term compliance maintenance.

Full Lifecycle Live Traceability

Jama Connect’s traceability matrix capabilities ensure complete visibility from user needs through design outputs, verification activities, and post-market surveillance. This end-to-end traceability is essential for demonstrating QMSR compliance during FDA inspections and supports efficient change management processes.

Built-in Regulatory Templates

Pre-configured templates for ISO 13485 and FDA requirements accelerate your compliance efforts. These templates provide structured approaches to requirements management while ensuring you capture all necessary information for regulatory submissions and quality system documentation.

Risk Management Integration

Jama Connect’s risk management capabilities enable you to capture, assess, and manage risks throughout your development process. Integration with requirements and design documentation ensures risk considerations remain visible and actionable throughout your product lifecycle.

Collaborative Quality Culture

The platform’s real-time collaboration features support the Culture of Quality that’s central to QMSR success. Team members across different functions can contribute to quality processes, ensuring quality considerations are embedded throughout your organization rather than isolated in quality departments.

Automated Reporting

Generate compliance reports efficiently with automated documentation features. This reduces manual effort while ensuring consistency and completeness in your regulatory submissions and quality system documentation.

Ready to streamline your transition to QMSR compliance? Discover how Jama Connect can support your transition with comprehensive traceability, integrated risk management, and collaborative reviews. Start your free trial today or schedule a demo to see how digital transformation can accelerate your regulatory success.

Tom Rish
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