QSIT Is Ending: How to Achieve Audit Readiness for Medical Devices Under FDA QMSR

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