FDA QMSR – An Overview

Under QMSR, manufacturers must establish and maintain a robust quality management system covering:

• Product design and development
   
• Production and process controls
   
• Risk management
   
• Corrective and preventive actions (CAPA)
   
• Post-market surveillance and reporting
   

This regulation enhances consistency, reduces regulatory burdens, and fosters greater global alignment in the medical device industry.

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RAPS – Your Compliance Partner for FDA QMSR

As global regulations evolve, RAPS stays ahead—guiding your organization through the transition to FDA QMSR with expert insights, system audits, and hands-on support.

 QMSR Readiness Assessments
ISO 13485 Gap Analysis
Training & Documentation Support
End-to-End Regulatory Compliance

Stay compliant. Stay competitive.
Get in touch with RAPS today to align your quality system with FDA’s QMSR and international best practices.

The FDA Quality Management System Regulation (QMSR) brings U.S. quality system requirements into closer alignment with the globally accepted ISO 13485 standard. This alignment is intended to help medical device manufacturers implement consistent, high-quality processes that support device safety and effectiveness throughout the product lifecycle.

The key components of QMSR include:

• Design Controls
  Establishing design and development processes to ensure devices meet user needs and intended uses.
   
• Risk Management
  Systematic identification, evaluation, and mitigation of risks at every stage of the product lifecycle.
   
• Corrective and Preventive Actions (CAPA)
  A structured system to detect, investigate, and eliminate causes of nonconformities and prevent recurrence.
   
• Process Control
  Ongoing monitoring and control of manufacturing activities to ensure product consistency and compliance.

Manufacturers currently operating under the FDA’s Quality System Regulation (QSR) will need to transition to QMSR as part of the FDA's harmonization initiative. This transition is critical to maintaining compliance and ensuring smooth global market access.

 Compliance Deadline: February 2, 2026
The FDA has officially set this date for QMSR implementation. Organizations should begin preparing now to avoid disruption and reduce the risk of non-compliance.
 

RAPS – Leading You Through the QMSR Transition

The shift to QMSR is more than a regulatory update—it’s an opportunity to strengthen your quality systems and align with global best practices.

With RAPS, you get:
Expert guidance on QMSR implementation
ISO 13485 readiness evaluations
CAPA system audits and training
Support for risk management and design controls

Stay ahead of regulatory change.
Start your transition to QMSR today with RAPS and ensure full compliance by 2026—without the stress.

The FDA’s QMSR rule is not just a regulatory update—it’s a global alignment that will define the future of medical device compliance.

 Compliance Deadline: February 2, 2026
Don’t wait until it’s too late. Start preparing now.

RAPS is here to guide you every step of the way.

 Expert support
Tailored compliance strategies
End-to-end QMSR transition services

Contact RAPS today and ensure a smooth, confident move from QSR to QMSR.