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by QT9 Software on February 24, 2026
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, marks one of the most significant shifts in medical device quality oversight in decades. In Part 1 of our discussion with Michelle Keane, QA/RA Director at Comply Guru, we focused on defining QMSR and ISO 13485 alignment.
Part 2 of the discussion explores what quality leaders really want to know:
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What will inspections look like under the rule?
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What is key to an organization successfully mastering QMSR compliance?
In this episode of the QT9 Q-Cast, host Christian Reyes continues the conversation with Keane, exploring the practical side of QMSR implementation — from training expectations to inspection strategy and leadership responsibility.
Contents
What FDA inspections will look like under QMSR
QMSR training: Understanding interconnected roles, systems and risk
Medical device manufacturers must keep risk top of mind
How digital QMS tools support QMSR compliance
How QMSR alignment may impact global market strategies
Why leadership engagement determines QMSR success
Final Takeaway: QMSR is an opportunity to modernize
Watch Part 2 of the QMSR podcast with Michelle Keane
What FDA inspections will look like under QMSR
Perhaps the biggest insight from our discussion with Keane is how FDA inspections are expected to change with the QMSR going into effect. Keane points to publication of the FDA’s new medical device inspection program, which replaced QSIT as of February 2.
Her biggest takeaway? Inspectors are not going to be looking at whether procedures were followed. Instead, she says, “they are validating whether leadership decisions make sense in the face of risk.”
FDA inspectors are expected to follow risk threads throughout a manufacturer’s processes, including complaint handling, CAPA, audit outcomes and management review. “I think that’s going to be the biggest shift in how the FDA are now going to be doing audits,” says Keane. “They’re going to be using data to inform the next step of the audit.”
Keane notes that it will be more difficult for manufacturers with siloed compliance data to demonstrate control, explain decisions and show traceability. “Inspectors are going to want to see data-driven decision making that’s based on risk,” she says.
That shift in inspection philosophy directly impacts how organizations must train their teams.
QMSR training: Understanding interconnected roles, systems and risk
As medical device manufacturers address QMSR compliance, one of their first steps will be communicating this new approach to employees. What do all employees need to know, and what should remain role-specific?
Keane emphasizes that training about the QMSR must inform an organization-wide understanding of how quality processes and product quality are connected.
“If I were to say to you what's the first thing I'm training people on, it's risk-based approach,” says Keane. “It’s about getting them to understand that it is an interlink of processes.” And that a change to a process can impact the system itself or the device.
Companies must understand mandatory documents needed and the operational processes required to build and support a medical device, and then apply risk-based controls. KPIs must be assigned to processes and how they interact, notes Keane.
“Once you have trained everyone to that concept, you then must train them to understand, when we make a change to this process, it could also make a change to our system or to the device itself,” says Keane. “Every role needs to see how they feed into the system overall.”
Quality can’t succeed when employees view compliance as “someone else’s job.” Every employee plays a role in the health of the quality system. “When people can see it as a system of interrelated processes and not see it as role specific, then you are setting yourself up for success in your system,” says Keane.
For example, a customer complaint isn’t just a service issue, it’s system input. It must be evaluated and fed back into the quality system because it may reveal deeper design problems.
How digital QMS tools support QMSR compliance
While Keane believes most medical device manufacturers have moved beyond paper quality management systems, Keane warns that technology alone doesn’t guarantee compliance. Where digital QMS platforms truly shine is in traceability and impact assessments.
“Some of the really cool features that have evolved in these systems are what I call spider web linkages,” says Keane. “Where you can click and you can immediately see, ‘If I make an update here, it’s going to impact this part of the system.’ That’s one of those tools that’s very visual and will facilitate organizations in identifying where there’s impact.”
That ability to visualize downstream effects can reduce human error and strengthen inspection readiness. “One of the biggest advantages of having an eQMS is that ability to automate… impact assessment,” says Keane. “If I make a change here, where is it felt downstream or upstream in my system?” That visibility is what strengthens impact assessment and audit readiness.
How QMSR alignment may impact global market strategies
Beyond inspections and internal controls, QMSR alignment may also influence broader market strategy. QMSR’s harmonization with ISO 13485 has the potential to shift medical device manufacturers’ market strategy worldwide.
“The transition to the QMSR will actually allow a cleaner, maybe quicker access to certain markets,” says Keane. She notes that regulatory reliance models and programs like MDSAP may become easier to leverage as global systems converge.
“This shift into QMSR really creates an opportunity for regulatory reliance and it could actually make it easier for you to get your product on the market.”
Why leadership engagement determines QMSR success
To master QMSR compliance, says Keane, leadership engagement is non-negotiable.
“You will not be able to successfully transition without that key leadership piece,” she says. And, she adds, quality management cannot be delegated away. “Where we see organizations failing… is where leadership says, ‘I hire you to do this. You handle it.’”
Instead, organizations must demonstrate commitment through documented decision-making and risk-based leadership behavior. “Show me how your leadership decision manages in the face of risk,” says Keane.
Final takeaway: QMSR is an opportunity to modernize
QMSR is not simply a new label for the old QSR. It represents a deeper shift toward risk-based, interconnected quality management, and FDA inspections will reflect that.
QT9's Reyes wraps it up nicely: “Treat it like a chance to modernize. Get serious about risk-based thinking … and connect your quality data so you can tell a clear story when the FDA shows up.”
If you haven’t listened to Part 2 of our QMSR discussion with regulatory expert Michelle Keane, of Comply Guru, now is the time. The insights in this episode are essential for quality and operations leaders preparing for the next era of FDA oversight.
QMSR Part 2 Podcast: Michelle Keane of ComplyGuru talks about employee and leadership roles in the new era of QMSR compliance.
QMSR compliance and QT9
By connecting complaints, CAPA, audits, training, supplier quality and management review within a single platform, QT9 enables organizations to maintain clear traceability and visibility across processes.
Built-in reporting and trend analysis enable teams to identify risk signals, evaluate system performance and document corrective actions in a way that aligns with FDA expectations for evidence-based decision-making. Validation documentation provided with QT9 QMS further supports compliance by helping organizations demonstrate that the system is fit for its intended use within their quality management framework.
QMSR reinforces that quality system compliance is no longer demonstrated by written procedures alone, but by how consistently organizations apply risk-based thinking and continuous improvement in practice.
Preparing for QMSR ultimately means changing how teams think about quality. Organizations that treat their QMS as a living system that continuously surfaces risk, informs decisions and drives corrective action, will be better positioned to demonstrate compliance and sustain inspection readiness over time.
For more on how QT9 QMS simplifies and streamlines compliance, reach out today.