Introduction to QMSR
Ready or not, QMSR is coming! - The FDA's new QMSR won't wait for you to catch up. Scared? Feeling Lost? That’s understandable. We are here to help ensure your Quality Management System is ready.
In February 2024, the FDA introduced new Quality Management System Regulations (QMSR) to incorporate ISO 13485:2016 by reference, creating significant changes in the compliance landscape by February 2026. If your QMS is primarily structured around the previous FDA regulations, or if you're a startup beginning to build your quality system, planning a smooth transition is crucial.
This introductory course simplifies the new FDA QMSR for medical devices, clarifies its alignment with ISO 13485:2016, and highlights key differences from the prior 21 CFR 820. Attendees will also learn about ISO 14971:2019 and understand the new regulatory expectations for Risk Management within the new QMSR framework.
The course will focus on:
1. Understanding New Regulations: We demystify the QMSR, clarify requirements and alleviate confusion, providing you with clear guidance to proceed confidently.
2. Gap Analysis and Strategic Compliance Roadmap: Learn to perform a gap analysis for your current QMS against ISO standards and QMSR and craft a compliance plan.
With our practical experience and proven strategies, attendees from companies of all sizes will gain the tools and insights to confidently navigate the transition, ensuring effective, authentic planning while making the most of available resources.
