QSIT Has Ended. Is Your Quality System Ready for QMSR?

For more than 25 years, medical device manufacturers prepared for FDA inspections under QSIT (Quality System Inspection Technique). That era has ended.

With the Quality Management System Regulation (QMSR), the focus is shifting from demonstrating that procedures were followed to demonstrating that the quality management system itself is effective, with greater emphasis on risk, leadership, suppliers, competency, CAPA and continuous improvement.

What does QMSR mean for FDA inspections?

Inspectors will increasingly look beyond individual records to understand how design, manufacturing, supplier quality, risk management, CAPA and post-market activities work together as a connected system.

How should medical device manufacturers prepare for QMSR?

This whitepaper from quality expert Dr. Joseph A. (Joe) DeFeo explores what the end of QSIT means and the practical steps quality leaders can take now.

Download the whitepaper to learn:

• What changes when FDA inspections move beyond QSIT
• Five QMSR readiness priorities for quality leaders
• How risk management and supplier oversight are evolving
• Why competency matters beyond training completion
• Five practical steps to prepare for your next FDA inspection

QMSR readiness isn’t just about updating documents. It’s about proving your quality system works.