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    Quality Management System Regulation:
    Key strategies to prepare for the transition

    Ensure your organization is ready for FDA’s QMSR transition

    Agenda

    07:22
    Understanding FDA QMSR Requirements: Navigating the Transition

    27:20
    Navigating Risk Management and Quality Management Reviews in the QMSR Transition

    36:20
    Preparing for QMSR: Key Strategies for a Successful Transition

    43:00
    Wrap Up

    The FDA’s new Quality Management System Regulation (21 CFR Part 820) goes into effect on February 2, 2026, aligning U.S. requirements with ISO 13485:2016. This shift will reshape how medical device teams prepare for inspections, manage risk, and demonstrate compliance.  In this training, Jennifer Mascioli-Tudor, Founder and CEO at JMT Compliance Consulting, and Angel Buendía, Scilife’s Knowledge Manager, will provide actionable insights into the QMSR transition, highlighting regulatory expectations and practical strategies to ensure your organization is ready. 

    You’ll learn how to:

    • Understand FDA QMSR Requirements: Navigating the transition.

    • Gain an understanding of the FDA’s QMSR and its implications for the medical device industry.

    • Navigate Risk Management and Quality Management Reviews in the QMSR transition.

    • Learn about key shifts in FDA expectations for Risk Management and Quality Management Review (QMR) as part of the transition.