Are you ready for the new QMSR?

FDA’s transition from Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) is on the horizon. The migration to QMSR will have far-reaching impact on how medical device manufacturers approach quality management systems…are you ready?

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.

Learn more about ELIQUENT’s QMSR solutions.