Regulatory clarity fromthoughttofinish
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. With key milestones approaching, a trusted regulatory partner is paramount to effectively navigate the changing landscape.
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.
MicroLearning
What is a MicroLearning?
MicroLearning is a focused, bite-sized learning experience designed to deliver key information in a quick, engaging, and easily digestible format. Instead of lengthy training sessions, micro-learnings break down complex topics into short, targeted lessons that can be completed in just a few minutes.
On this page, you’ll find micro-learnings on the FDA’s Quality Management System Regulation (QMSR)—helping you stay up to date with key regulatory requirements, compliance expectations, and industry best practices. 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!
From QSR to QMSR
Watch our MicroLearning and discover what’s Changing and Why It Matters
The FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant shift in how medical device manufacturers must approach compliance. This micro-learning provides a quick, essential overview of what’s changing and why it matters for industry stakeholders.
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!
More QMSR Resources
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. Start exploring now to stay informed and ensure a seamless transition to QMSR!
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