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QMSR Solutions
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.
Specialized Services
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.
Compliance (Gap) Assessments
Our industry-recognized team guides companies to sustainable success with comprehensive technical process audits that identify areas of non-compliance and provide a roadmap to achieve full alignment with the new QMSR.
Quality Systems Strategy
Clients count on ELIQUENT to develop customized, effective and efficient quality systems that transition organizations to the new QMSR framework with best-in-class direction on design, optimization, and implementation.
Inspectional Readiness
ELIQUENT applies extensive regulatory expertise to develop and implement custom strategies that prepare companies for the QMSR’s enhanced FDA inspectional responsibilities, while aligning with global regulatory standards and expectations.
Post-Market Surveillance
With ELIQUENT’s strategic direction and hands-on support, companies can confidently transition to the new QMSR with a robust post-market surveillance system that meets compliance requirements and enhances overall business performance.
Regulatory Engagement
ELIQUENT experts bring an unmatched level of credibility and trust when interacting with global regulators by providing valuable guidance on regulatory communications, meetings, and correspondence with regulatory authorities.
Compliance & Enforcement Actions
Our deep bench of former FDA officials and industry experts provide full-service engagement and objective advice to successfully guide companies as they encounter complex regulatory compliance and enforcement actions.
Consultation & Regulatory Guidance
ELIQUENT goes beyond traditional consulting to address the entire product lifecycle. Our market leading insight and global solutions equip companies with solutions that reduce the risk of non-compliance while enhancing operational efficiency, product quality, and market access.
Expert Training
Built on the industry’s largest portfolio of quality and regulatory training content and world-class instructional design capabilities, ELIQUENT experts create broad QMSR training solutions across the entire product life cycle that empower teams to elevate regulatory compliance and optimize quality management practices.
Unmatched Expertise
ELIQUENT brings the unmatched expertise that companies need when adapting to the evolving regulatory framework. With decades of experience, our team of professionals have directly influenced significant policy decisions and regulatory actions through their service at global regulatory authorities. The team’s combined capabilities and experience building effective and sustainable Quality Management Systems enable a cross-functional, full-service engagement that unlocks regulatory excellence.
Brian Burns
Recognized medical device industry expert with extensive experience leading large-scale enforcement-related remediation programs.
David Elder
23-year veteran of the FDA with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions.
Kristen Grumet
25-year compliance career including nearly a decade as an FDA Field Investigator specializing in medical devices and quality systems compliance.
John Love
20+ year life sciences background of driving regulatory compliance through instructional design, development, and delivery.
Janet Whipple
35 years of experience in medical device, in-vitro diagnostic and combination product quality, regulatory compliance, design, and operations.
Carolyn Tomlinson
30+ years of Life Science industry experience in quality system development, management, auditing, training and consulting.
ELIQUENT Insights
ELIQUENT’s premier team of regulatory experts routinely share their deep industry knowledge and hands-on experiences as industry thought leaders. Explore unique perspectives, actionable insights, and resources to drive your business forward.
WHITE PAPER: FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know
FDA defined a 2-year transition for the QMSR with the amended regulation coming into effect on February 2, 2026. Learn what the harmonization from QSR to QMSR means for medical device companies.
Regulatory Resources.
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ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists partners with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
Learn more about ELIQUENT’s integrated LDT solutions and how our team of experts unlocks regulatory excellence:
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