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February 18, 2026

A medical compliance expert discussing QMSR audit questions and documentation with a medical device manufacturer.

QMSR audit questions for inspection program readiness

FDA Inspections Team / February 18, 2026

Medical professionals using high-tech digital monitoring and diagnostic displays to ensure medical device quality and patient safety during a clinical assessment.

common gaps in medical device inspection programs under QMSR

FDA Inspections Team / February 18, 2026

A professional doctor or compliance auditor explaining regulatory documentation and QMSR audit readiness requirements to a medical device manufacturer representative.

QMSR audit readiness tips for medical device inspection programs

FDA Inspections Team / February 18, 2026

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