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QA/RA Consulting, Auditing & Training
In Part I, we explored why FDA inspections feel different under QMSR: inspectors are following risk, connecting information across the product lifecycle, and evaluating how quality systems actually function in practice. For software-driven products, those same shifts are even more apparent. When the device is software—or relies heavily on software—FDA’s focus extends beyond procedures and documentation to how software risks, changes, and performance are managed throughout the lifecycle.
For SaMD and software‑heavy devices, QMSR reinforced something FDA already believed: software is never “done” at release. Inspections now follow how software is designed, changed, deployed, monitored, and corrected across the full lifecycle.
That aligns directly with:
Under QMSR’s risk‑based inspection model, FDA investigators increasingly use the following to decide which parts of your system will be scrutinized the most:
For SaMD teams, this maps cleanly to IEC 62304, but FDA now expects risk management to actively shape decisions, not simply document severity levels.
Many software teams are strong on IEC 62304 task completion (plans, traceability, verification), but FDA inspections under QMSR are:
FDA has been very consistent: QMSR does not regulate algorithms directly. Instead, inspections ask:
This focus mirrors FDA’s AI/ML guidance emphasizing total product lifecycle management, not one‑time validation.
For SaMD and AI‑enabled devices, inspections often feel more intense because:
QMSR makes change control a core inspection area, not a supporting function.
Under QMSR, FDA expects SaMD manufacturers to actively use the following as inputs to risk management and future changes:
This expectation ties together:
FDA inspections now consistently probe:
This is particularly relevant for AI and SaMD, for which technical teams historically made many decisions informally.
As a final note: QMSR didn’t change how good software is built – it changed how clearly software decisions must be controllable, explainable, and repeatable under inspection.
ELIQUENT helps manufacturers respond to FDA’s QMSR inspection approach through:
Reach out to ELIQUENT Life Sciences to learn how we can help you act on these early QMSR enforcement signals.
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