QSIT Is Ending:
How to Achieve Audit Readiness for Medical Devices Under FDA QMSR
About this webinar
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.
Who should attend
- Medical device companies preparing for upcoming FDA audits
- Quality Directors and Managers
- Regulatory Affairs professionals
- Internal compliance and quality auditors
- Operational leaders who support FDA audits and inspections
What you will learn
- Explaining the implications of the shift from inspection-based QSIT to a system-based QMSR approach aligned with ISO expectations
- Enabling leadership engagement to support management review and a culture of quality under QMSR
- Using a readiness assessment to prepare for FDA audits under QMSR
Featured Speakers
Dr. Joseph (Joe) DeFeo
With 35+ years of global experience and mentorship under Dr. Joseph M. Juran, Joe DeFeo has led global transformations aligned to global standards like ISO 9000, AS 9100/9145 and GMP-based QMS frameworks. As a pioneer in Lean, Six Sigma and Quality by Design, Joe brings unmatched insights into building world-class quality systems that drive sustainable results.
Partner for this event
ComplianceQuest
ComplianceQuest is an AI powered platform for Product Lifecycle (PLM), Quality (QMS), Environmental, Health & Safety (EHS) and Supplier Management (SRM/SQM), built natively on Salesforce platform.
Our connected suite of solutions helps businesses of all sizes enhance quality, safety, and efficiency throughout the product journey, from concept to customer success.
By offering a data driven and integrated platform that is pre validated and easy to implement, ComplianceQuest improves collaboration across the product value chain, reduces risk, protects employees and brand reputation, and helps organizations boost innovation, compliance, profitability, and customer loyalty.
