Prepare Your Quality Management System for QMSR Compliance by February 2026

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current Quality System Regulation (QSR) and align with ISO 13485:2016, marking a notable evolution in quality management practices for medical device production.

Key Changes Under QMSR

1. Supplier Quality Agreements
   Under the new QMSR, supplier quality agreements will need to reflect the standards set forth in ISO 13485:2016. This alignment may require companies to revisit existing agreements, ensuring they meet the more comprehensive traceability and documentation standards of ISO.
2. Enhanced Traceability Requirements
   The QMSR will mandate thorough traceability between design inputs and outputs, a step beyond what was previously required by the QSR. This shift emphasizes the importance of maintaining clear, documented connections throughout the design and development process.
3. Expanded FDA Oversight
   Records that were previously exempt from FDA inspection, such as Management Review reports and internal/supplier quality audits, will now be accessible during FDA inspections. This change may necessitate a more rigorous approach to documentation and internal review processes to ensure readiness for potential FDA scrutiny.
4. Updated Inspection Program
   The FDA has announced plans to implement a new inspection program tailored to QMSR, impacting how future audits and inspections are conducted. This program will be designed to align with ISO 13485:2016 standards, and manufacturers should expect this transition to bring increased attention to their compliance with global standards.

Steps to Take Now

To prepare for the February 2026 deadline, manufacturers should begin making adjustments to their quality systems and ensure their teams are well-versed in the differences between the QSR and QMSR. Here are some suggested steps:

• Review and Update Documentation
  Conduct a comprehensive assessment of existing processes and documentation, identifying areas that may require adjustment to align with QMSR standards.
• Update Supplier Agreements
  Collaborate with suppliers to revise quality agreements, emphasizing the need for enhanced traceability and alignment with ISO 13485:2016.
• Enhance Internal Training
  Educate personnel on the new QMSR requirements, particularly those involved in documentation, auditing, and management review processes, to ensure readiness for the updated FDA inspection protocols.
• Evaluate Compliance for Planned Submissions
  For those planning submissions such as Humanitarian Device Exemptions (HDE) or Premarket Approvals (PMA) in 2025, assess whether these submissions will need to comply with QSR or QMSR, based on the anticipated timing.

By proactively addressing these aspects of the QMSR, manufacturers can position themselves for a smoother transition. Preparing early allows for the necessary adjustments to documentation, supplier relations, and internal processes, ensuring compliance with the new standards by February 2026. As always, staying informed about regulatory changes and engaging in continuous quality improvement will be key to navigating this regulatory shift successfully.

If your team needs extra support in preparing for the QMSR transition, we’re here to help. Our experienced consultants are ready to provide strategic guidance, review your quality systems, and assist with documentation updates to ensure compliance by the February 2026 deadline. To discuss how we can help make your QMSR transition as seamless as possible, please contact: brette@qualitysolutionsnow.com.