RQM+ is a global MedTech service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.

Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our: 
• Regulatory and Quality Consulting
• Lab Services (Jordi Labs)
• Clinical Trials
• Reimbursement
• Technology Solutions


RQM+

The FDA's long-awaited Final Rule on Laboratory Developed Tests (LDTs) is here, marking a significant shift in the regulatory landscape for diagnostic testing. Released on April 29th, 2024, and published in the Federal Register on May 6th, this rule brings LDTs under the same regulatory umbrella as other in vitro diagnostic (IVD) devices. The FDA believes this change will better protect patient health and safety by ensuring consistent oversight and quality standards across all diagnostic tests.

Join us for an insightful webinar where RQM+ Director for IVD Global Regulatory Affairs, Margot Borgel, and Senior Principal Consultant and IVD expert, Bethany Chung, will dive into the key provisions of the Final Rule, its impact on laboratories, and actionable strategies for successful compliance. They will draw from their deep expertise and discussions at the recent Association of Medical Diagnostics Manufacturers (AMDM) annual meeting to provide you with the most up-to-date insights.

In this webinar, you will:

*   Understand the expanded enforcement discretion for certain LDTs, including grandfathering provisions for currently marketed tests
*   Explore the phased implementation approach over four years and key compliance milestones
*   Learn about the explicit classification of LDTs as medical devices and its implications
*   Discover actionable insights and preparation strategies, including compliance readiness, documentation and process improvement, and staff training
*   Gain valuable guidance on navigating the evolving regulatory landscape and ensuring seamless compliance

Who should attend:

*   Quality Assurance Managers and Directors
*   Regulatory Affairs Professionals
*   Laboratory Managers and Directors
*   Product Development Teams
*   Clinical Affairs Professionals
*   Compliance Officers

Please complete the form to register for this informative webinar and join us live to ask questions! All registrants will receive a recording of the session and a copy of the presentation slides.
