The FDA’s transition to the Quality Management System Regulation (QMSR) represents a shift in how medical device inspections are conducted. While the regulation aligns more closely with ISO 13485, the inspection approach itself has also evolved. 

Many professionals continue to interpret inspections through the lens of the previous QSIT model, which may no longer reflect current FDA practices. This can lead to gaps in understanding how inspections are now structured and evaluated. 

This webinar explains the updated FDA inspection paradigm, including how the agency applies a more risk-based and process-focused approach, and how elements such as management responsibility, quality systems, and patient risk are assessed during inspections. 

It also provides clarity on how FDA expectations differ from ISO certification and where organizations may need to reassess their current compliance approach. 

After this webinar attendees will be able to answer-

• What has actually changed in FDA inspections under the new QMSR framework 
• How the removal of QSIT impacts inspection preparation and expectations 
• Where organizations may still be relying on outdated compliance assumptions 
• How risk management (ISO 14971) now influences inspection focus 
• What FDA investigators are now prioritizing during inspections 
• Why ISO alignment does not eliminate the need for FDA-specific readiness 

This webinar benefits the following agencies-

• Medical device manufacturers 
• Regulatory compliance teams 
• Quality management departments 
• FDA-regulated organizations preparing for inspections 
• Companies aligning with ISO 13485 and FDA QMSR 

Who should attend?

• Regulatory Affairs Professionals 
• Quality Assurance & Quality Control Managers 
• Compliance Officers 
• Medical Device Manufacturers & Consultants 
• Professionals involved in FDA inspection readiness and audit preparation