QA/RA Consulting, Auditing & Training
Introduction
FDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). That alone is a big deal. Combined with the rollout of the Quality Management System Regulation (QMSR), it signals a very real shift in how FDA expects manufacturers to think about, operate, and defend their quality systems.
While QMSR has been discussed for some time, the inspection implications are just now landing. Inspections are becoming more focused on risk-based decision making throughout the quality system to evaluate whether processes and operations work, day in and day out.
This blog post gets straight to the point: We focus on what the new inspection compliance program means in practice and begin with a concise QMSR refresher to set the stage.
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QMSR Explained Simply
At its core, QMSR replaces FDA’s legacy Quality System Regulation with a framework that better reflects how modern quality systems are expected to function. The goal is not to do more paperwork; rather, the goal is better alignment, clearer accountability, and stronger risk-based decision making.
Manufacturers had ample opportunity to prepare for QMSR. Rather than rehashing the full comparison of QMSR vs. QSR here, we recommend reviewing the ELIQUENT blog “From QSR to QMSR: What’s Changing and Why It Matters” that walks through QMSR versus the prior regulation in detail.
What feels familiar under QMSR are the fundamentals: design controls, CAPA, supplier controls, complaint handling, and internal audits. What has changed: There is now a heightened expectation that these processes operate as a connected system informed by risk and actively overseen by management.
This distinction matters, because it is foundational to an effective quality management system – one that consistently supports safe and effective medical devices. FDA inspections tend to reveal whether that foundation is truly in place. ________________________________________
Inspection of Medical Device Manufacturers Compliance Program
Purpose of the Program
The Inspection of Medical Device Manufacturers Compliance Program defines how FDA investigators plan and conduct quality system inspections. It provides a structured approach for evaluating whether a manufacturer’s quality system is designed and implemented to consistently meet regulatory requirements.
The program is not intended to be a simple checklist – its purpose is to assess system integrity, risk control, and the manufacturer’s ability to identify and address issues proactively.
High Level Inspection Structure and Intent
While the updated compliance program replaces QSIT, it does not fundamentally change the overall structure of FDA medical device establishment inspections. Investigators will continue to assess core quality system processes using a risk-based approach, with flexibility to adjust depth and focus based on product risk, compliance history, and observed system performance.
The significance of the update is less about inspection mechanics and more about how investigators interpret and connect quality system activities under QMSR.
What Investigators Are Evaluating
At the quality system level, investigators are evaluating:
The inspection experience increasingly evaluates how the quality management system behaves under real world conditions.
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How QMSR Changes the Inspection Experience
Inspections are at the heart of the change. QMSR may be a regulation, but inspections are where it becomes real.
From Discrete Subsystems to an Integrated View
This is where many teams get surprised.
Under QSIT, inspections often felt compartmentalized. Design controls were reviewed separately from CAPA, supplier controls, or postmarket activities. While linkages existed, they were not always explored deeply unless a specific issue triggered further review.
Under QMSR, investigators are more intentionally connecting processes. Discussions are increasingly centered on how information flows across the quality system. A design issue may lead directly to risk management, complaint trending, CAPA prioritization, and management review discussions.
Manufacturers should expect fewer isolated questions and more end-to-end conversations about how issues are identified, assessed, escalated, and resolved.
Inspection reality: Investigators are following the story, not just the flowchart utilized with QSIT.
Greater Emphasis on Risk-Based Decision Making
If risk management lives in a file instead of driving decisions, it will show.
Risk management is no longer treated as a standalone activity or a static file. Investigators are evaluating how risk-based thinking influences day-to-day decisions across the organization. This includes:
Organizations that cannot clearly explain why certain risks were accepted, mitigated, or deprioritized may struggle, even if documentation appears complete.
Focus on Effectiveness Over Formal Compliance
Documenting a process is necessary to comply with FDA and other regulatory bodies, but demonstrating a process’s effectiveness is what matters. QMSR shifts inspection emphasis away from procedural completeness toward system effectiveness. Investigators are asking whether processes work as intended. Examples include:
Well-written procedures are no longer sufficient on their own. The expectation is that outcomes will demonstrate control.
Increased Scrutiny of Management Oversight
Leadership engagement is no longer assumed. It is evaluated.
Management responsibility is central under QMSR, and inspections reflect that. Investigators are spending more time evaluating how leadership governs the quality system. This includes assessing:
Management review that functions as a reporting exercise, rather than a decision-making forum, is increasingly visible during inspections.
Inspection Conversations Are Now More Narrative
This is another area where teams often underestimate the shift.
Investigators are building narratives across inspection activities rather than just checking individual requirements. Teams are being asked to explain how their quality system operates in practice, how issues are handled when things go wrong, and how learning is fed back into the system.
Organizations that prepare teams to coherently explain processes, decisions, and rationale are better positioned than those that focus solely on document availability.
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Key Differences Between QSIT and the QMSR Inspection Approach
The table below summarizes the inspection approach under QSIT compared to inspections aligned with QMSR expectations. While FDA inspection fundamentals remain, the lens through which investigators evaluate quality systems has clearly shifted.
Inspection Dimension | QSIT-Based Inspection Approach | QMSR-Aligned Inspection Approach |
Overall focus | Verification of compliance with defined subsystems and requirements | Evaluation of overall quality system performance and effectiveness |
Structure | Linear review of discrete subsystems | Integrated, end-to-end assessment across processes |
Use of risk management | Often reviewed as a standalone activity, primarily tied to design | Reflected through risk-based process controls and decision making across the quality system |
Documentation emphasis | Heavy focus on procedures and records | Focus on whether documentation reflects real-world practice |
Decision-making rationale | Confirmation that required steps were followed | Examination of why decisions were made and how risk was weighed |
CAPA evaluation | Emphasis on timely closure and documentation | Emphasis on root cause quality and prevention of recurrence |
Management involvement | Management responsibility generally implied | Management oversight actively evaluated and discussed |
Inspection conversations | Requirement-driven and transactional | Narrative-driven, connecting signals across the system |
For organizations accustomed to QSIT-based inspection preparation, this comparison highlights why inspection readiness under QMSR requires more than just updating procedures – teams must be able to explain how their quality system operates as a cohesive, risk-informed unit.
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Common Readiness Gaps Seen Across the Industry
Readiness gaps are not new problems. QMSR simply makes them far more visible.
Across industry, the same issues continue to surface during inspections. QMSR does not create these gaps, but it does make it harder to hide.
Documentation That Does Not Reflect Practice
One of the most common gaps is misalignment between documented procedures and actual operations. Investigators quickly identify when practices have evolved but documentation has not. This gap erodes credibility and invites deeper inspection.
Risk Management Operating in Silos
Risk management is often treated as a design phase activity rather than a living process. When risk files are disconnected from complaints, CAPA, or supplier issues, it signals weak system integration.
Weak Management Oversight and Governance
Another frequent finding involves management review that focuses on metrics without clear decisions or follow up actions. Under QMSR, leadership accountability is central, not symbolic.
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Practical Preparation Strategies
Strong inspection outcomes start long before FDA arrives. Good preparation under QMSR is less about rewriting procedures and more about strengthening how the organization operates.
Assess Readiness Now
Organizations should conduct structured QMSR readiness assessments that evaluate not only compliance gaps but also system effectiveness. This includes reviewing how processes interact and how decisions are made.
Early assessments allow time to correct foundational issues rather than being forced to react under inspection pressure.
Prepare People and Processes, Not Just Documents
Effective preparation includes:
Inspection readiness depends as much on how teams respond to questions as on what is written.
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Conclusion
QMSR and the retirement of QSIT represent a real shift in how FDA evaluates medical device quality systems. Inspections are now more focused on system performance, risk-based decision making, and visible leadership oversight. Organizations that deliberately prepare for inspections are better positioned to navigate those inspections with confidence and will avoid reacting under pressure.
ELIQUENT supports medical device manufacturers at every stage of this transition, combining regulatory depth with hands-on inspection experience.
For organizations looking to build awareness and alignment quickly, ELIQUENT offers a 1-day FDA QSR to QMSR Transition Training class designed to help teams understand what is changing, what is not, and how inspection expectations are evolving.
For teams seeking a deeper, system-level understanding, ELIQUENT’s 3-day QMS, ISO 13485, and FDA QMSR Training class provides comprehensive instruction on building and sustaining an integrated, inspection-ready quality management system.
Beyond training, ELIQUENT provides quality system audit and consulting services to help organizations assess QMSR readiness, prepare for FDA inspections, and strengthen quality system effectiveness before, during, and after an inspection.
Whether you are just starting your QMSR transition or preparing for an upcoming FDA inspection under the new inspection approach, ELIQUENT can partner with your team to turn regulatory change into practical, sustainable improvement.
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This article reflects ELIQUENT Life Sciences’ interpretation and application of publicly available FDA regulations and inspection frameworks, informed by extensive hands-on inspection and quality system experience.
References
1. From QSR to QMSR: What’s Changing and Why It Matters
https://eliquent.com/qmsr-resources/
2. It’s Here! FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know
https://www.orielstat.com/blog/fda-qsr-vs-qmsr/
3. FDA Inspection of Medical Device Manufacturers Compliance Program
https://www.fda.gov/media/80195/download
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One of the first questions you may have when you’re looking through the ISO 13485:2016 requirements is about the phrase “applicable regulatory requirements.” That phrase is used throughout the standard to require organizations to identify all of the global regulatory requirements that are relevant to their organization’s quality system. But if FDA is following this requirement, does that mean they will be asking you about how you meet the quality system requirements for all the countries where you market your devices? Fortunately, no. FDA has made it clear in QMSR 820.10(b) that the “applicable regulatory requirements” for FDA will be only other US regulations (e.g., 21 CFR Part 803 for reporting to regulatory authorities).
Check out our previous QMSR blog that walks through the big changes from the QSR to the QMSR:
Of course, first you should read the QMSR and become familiar with the new structure and content of 21 CFR Part 820. The entire Regulation has been replaced with a new structure in QMSR – it is not just a revision of the existing QSR with sections taken out or replaced.
You also need to make sure you understand the full requirements of ISO 13485:2016. Even though it is “substantially similar” (in FDA’s opinion), there are still details within the standard that are not included explicitly in the QSR today.
If you are new to ISO 13485:2016 and need a copy quickly, you can view the standard content online via the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal. However, this online version is a read-only format, and you must register on the site each time you wish to see the document – not very convenient for your day-to-day work. For longer-term use, you need to purchase the standard for your organization. Once you have the standard, read it through from beginning to end, including the introduction (Clause 0).
The new Quality Management System Regulation (QMSR) – FDA’s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 – is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin enforcing the QMSR requirements.
The major change coming for those organizations who fall within the scope of the Regulation is the “incorporation by reference” of the requirements of ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes. ISO 13485 was introduced in 1996, which happens to be the last time a major update to 21 CFR Part 820 (QSR) occurred. Since that time, ISO 13485 has been modified a few times, and the most recent version – ISO 13485:2016 – is very similar to FDA QSR. In fact, many people with knowledge of the QSR and ISO 13485:2016 talk about the two containing nearly the same requirements.
This incorporation of ISO 13485:2016 by reference in the QMSR makes the ISO 13485:2016 requirements the basis for quality system compliance for manufacturers of medical devices, in-vitro diagnostics, and combination products with a device constituent marketed in the US. This approach means that all companies required to comply with the QMSR will essentially be following ISO 13485:2016 – even if they are not certified to the standard by a third party.
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