How AI Can Reduce Inspection Risk and Strengthen QMSR Readiness, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insights into the shift from QSR to QMSR, one of the most significant changes to medical device regulation in decades. Attendees will gain a better understanding of validated digital systems aligned with 21 CFR Part 11 and GAMP 5. The featured speakers will discuss integrating ISO 14971 risk management throughout the QMS lifecycle. Attendees will also gain insight into reactive vs. proactive risk models.

TORONTO, April 28, 2026 /PRNewswire/ -- The shift from QSR to QMSR represents a major regulatory change for medical device organizations. In 2026, the FDA is no longer focused solely on a trail of paperwork; it is evaluating whether companies can demonstrate a living, breathing, risk-integrated system. This shift moves the industry from documentation-based compliance to a model where ISO 14971 risk management must be woven into every thread of the organization. This webinar explores how organizations can respond to that shift by moving from reactive quality practices to a more proactive, integrated approach.

The challenge is that most legacy systems were not designed for this level of integration. When risk data lives in a vacuum, the QMS becomes a liability during an inspection. Under the new QMSR framework, investigators are prioritizing systemic effectiveness across connected quality processes. If change controls, CAPAs and supplier audits operate in silos rather than as part of an integrated quality system, organizations may be more vulnerable during inspections.

Rather than focusing on isolated corrective actions after issues arise, a proactive approach to QMSR readiness emphasizes cross-functional alignment, integrated risk management and stronger traceability across the QMS lifecycle. The webinar will also touch on how AI and digital tools can support visibility, traceability and more informed decision-making within a proactive quality framework. Attendees will learn how to align QMS practices with evolving FDA expectations and support a more consistent approach to compliance.

Register for this webinar to learn how QMSR readiness supports a proactive quality strategy that reduces inspection risk, with insights from AVS Life Sciences.

Join Mandy Gervasio; Lauren Mermelstein and Divya Gowdar, for the live webinar on Tuesday, May 19, 2026, at 12pm EDT (6pm CEST/EU-Central).

For more information, or to register for this event, visit How AI Can Reduce Inspection Risk and Strengthen QMSR Readiness.

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