The FDA is no longer just looking at how you build your device; they are scrutinizing how you protect it. This session deconstructs the transition from the legacy Quality System Inspection Technique (QSIT) to the Quality Management System Regulation (QMSR), while integrating the high-stakes requirements of Section 524B.

We will move past the theory and focus on the practical "pain points" of the new inspection manual, specifically how ISO 13485:2016 alignment changes the way investigators walk your floor.

Key Learning Objectives:

• The QMSR Pivot: Understand how the FDA’s harmonized approach shifts the focus from "checking boxes" to evaluating the effectiveness of your Quality Management System under ISO standards.
• Enforcement of Section 524B: Analyze why cybersecurity is no longer a "best practice" but a legal mandate, and what the FDA classifies as a prohibited act during an audit.
• Tactical Documentation: Identify the specific evidence—from Software Bills of Materials (SBOMs) to vulnerability disclosure plans—that investigators now expect to see during routine inspections.
• Audit Readiness for "Cyber Devices": Learn how to update your internal audit program to mirror the new FDA and MDSAP frameworks, ensuring your team isn't blindsided by the expanded scope of foreign and domestic inspections.

The Reality Check: Under the new manual, a gap in your cybersecurity documentation isn't just a suggestion for improvement—it’s a direct hit to your regulatory compliance status.

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