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QMSR Resources
From QSR to QMSR: What’s Changing and Why It Matters
The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a pivotal shift for the medical device, in-vitro diagnostic, and combination product industry.
The migration to QMSR will have far-reaching impact on how medical device manufacturers approach quality management systems. The new streamlined regulation is harmonized with internationally recognized QMS standards and emphasizes a data driven risk-based approach that introduces updated processes for quality management and enhanced inspectional responsibilities for regulators.
ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide tailored solutions that ensure a smooth and successful adaption to the new framework. Together, we unlock regulatory excellence.
QMSR Webinar
Medical Device Manufacturers – Are you ready?
The FDA will transition from QSR to QMSR in less than one year. Prepare for the shift with ELIQUENT Life Sciences’ complimentary QMSR webinar where ELIQUENT experts Kristen Grumet, Carolyn S. Tomlinson and David Elder will share insights and strategies to confidently navigate the upcoming changes.
Register today for this complimentary webinar.
Ready to enhance your QMSR knowledge?
To help you navigate the shift from QSR to QMSR, we’ve compiled essential resources to ensure your organization stays compliant, audit-ready, and aligned with ISO 13485.
Our QMSR Resource Hub provides expert-driven content designed to help you understand and stay ahead of new and updated regulatory requirements. Start exploring now to stay informed and ensure a seamless transition to QMSR!
MicroLearnings
Short on time? ELIQUENT’s QMSR MicroLearnings are designed to deliver key information in a quick, engaging, and easily digestible format. These short, high-impact lessons are perfect for busy professionals who need relevant, practical insights without the time commitment of traditional training.
Explore our QMSR micro-learnings and build your expertise, one lesson at a time!
Discover What’s Changing
& Why It Matters
This micro-learning is perfect for regulatory, quality, and compliance professionals looking for a concise, practical breakdown of the QMSR transition. Stay informed and stay compliant—watch now!
QMSR Solutions
A strong quality program is a cornerstone of regulatory success. For medical device, in-vitro diagnostic, and combination product manufacturers, realignment to the FDA’s new QMSR is critical to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
As the industry leader in quality and compliance solutions, ELIQUENT partners with companies to ensure a seamless to the new regulation while maintaining regulatory compliance and product excellence.
Learn more about ELIQUENT’s QMSR Solutions