QSIT Is Ending: How to Achieve Audit Readiness for Medical Devices Under FDA QMSR, Upcoming Webinar Hosted by Xtalks

In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a system-based QMSR approach aligned with ISO expectations. The featured speaker will discuss how to enable leadership engagement to support management review and a culture of quality under QMSR. Attendees will gain insight into using a readiness assessment to prepare for FDA audits under QMSR.

TORONTO, March 3, 2026 /PRNewswire/ -- The US FDA has retired its QSIT (Quality System Inspection Technique) requirements for medical devices and introduced the Quality Management System Regulation (QMSR). This webinar examines the implications of this regulatory shift for audit readiness and how organizations can prepare for FDA inspections aligned with QMSR expectations.

"Big Q" thinking means a company must demonstrate a quality system that proactively manages and prevents risk across the organization, rather than simply reacting to them. This system must align with the ISO 13485 Risk Standard, the ISO 9001 Quality Standard and other applicable regulatory requirements, placing increased emphasis on leadership engagement, management review and end-to-end accountability.

Although medical device companies have had two years to prepare for the QMSR transition, uncertainty remains about how the FDA will prioritize compliance efforts under these new requirements.

In this webinar, the speakers will cover:

• How FDA inspections may feel different under QMSR compared to QSIT
• Where organizations are commonly underprepared for system-based audits
• How leadership engagement supports audit readiness under QMSR
• Practical steps to assess and strengthen quality systems ahead of FDA audits

Register for this webinar to learn how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR.

Join Dr. Joseph (Joe) DeFeo, Chief Quality & Advocacy Officer, ComplianceQuest, for the live webinar on Thursday, March 5, 2026, at 10am EST (3pm GMT/UK).

For more information, or to register for this event, visit QSIT Is Ending: How to Achieve Audit Readiness for Medical Devices Under FDA QMSR.

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