In a major regulatory shift announced at MedCon 2025, the FDA confirmed that the Quality System Inspection Technique (QSIT), the long-standing framework for medical device inspections, will be retired with no replacement version. The FDA will now align its inspectional approach with ISO 13485:2016, as outlined in the updated  Medical Device Compliance Program

This is a significant departure from the subsystem-focused model that’s guided FDA inspections for over two decades. It signals a broader move toward global harmonization and a more process-oriented methodology, bringing both opportunities and challenges for MedTech manufacturers.

What This Means for Your Quality System 

QSIT has been a familiar tool in regulatory preparation, but its retirement means manufacturers must adapt quickly. The FDA's new approach emphasizes process over structure, following the ISO and MDSAP audit philosophies. 

One of the biggest changes is the heightened emphasis on risk management across all quality system elements, not just in design or production. Additionally, until the Quality Management System Regulation (QMSR) goes into full effect in February 2026, companies will need to maintain compliance with the legacy QSR ISO standard, a dual burden that may strain internal teams. 

And while the FDA is investing in training its investigators, many will still be navigating their own learning curves. This adds a layer of unpredictability during inspections, especially in the near term.

Why Acting Now Is Critical  

 Companies that succeed during this transition will be those that proactively prepare. That means not only updating procedures, but also translating the language of QSIT into ISO terminology, ensuring documentation aligns with evolving expectations, and preparing teams for more rigorous audits. 

This isn’t just a change in formatting, it's a philosophical shift in how compliance is evaluated. 

 How Rook Quality Systems Can Help

 At Rook Quality Systems, we’re already working with clients to prepare for this transformation. Our consultants bring dual expertise in FDA inspections and ISO 13485/MDSAP audits, allowing us to guide your team through both the strategic and practical implications of this change.

We can help you:

• Build a transition roadmap tailored to your current systems and future goals
•  Identify and address gaps between QSR and ISO 13485 compliance
• Train your team to confidently manage inspections and internal audits
•  Support documentation updates and risk-based planning that meets new expectations
  
  

Whether you’re preparing for an upcoming inspection or want to future-proof your QMS, RQS can help you navigate this pivotal regulatory moment with confidence.