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February 20, 2026

Three professionals in business attire sit around a conference table, reviewing documents and preparing for an FDA QMSR Inspection Program Audit. A whiteboard behind them lists key topics like Quality System Regulations (QSR), ISO 13485 standards, gap analysis, and mock audits.

Inspections

Preparing For FDA QMSR Inspection Program Audit

FDA Inspections Team / February 20, 2026

An infographic outlining the steps to fix inspection program gaps in Quality Management System Reviews (QMSR), including identifying gaps, analyzing root causes, updating procedures, training staff, and monitoring progress for continuous improvement.

Inspections

How To Fix Inspection Program Gaps In QMSR

FDA Inspections Team / February 20, 2026

Medical tablet displaying health data with heart rate and blood pressure graphs, surrounded by a stethoscope, glasses, and papers on a desk.

Inspections

Common QMSR Inspection Program Challenges For Medtech

FDA Inspections Team / February 20, 2026

A scientist in a lab coat analyzes medical imaging data on multiple computer screens, displaying brain scans and diagnostic information in a high-tech lab setting.

Inspections

QMSR Medical Device Regulation Inspection Guidance Document

FDA Inspections Team / February 20, 2026

A medical professional and technician reviewing a brain scan on a monitor while a patient lies on a medical examination table.

Inspections

Best Practices For Medical Device Inspection Program QMSR Compliance

FDA Inspections Team / February 20, 2026

A comparison of the QMSR and ISO 13485 inspection programs, featuring two professionals. On the left, an FDA auditor reviews a QMSR audit checklist, while on the right, a healthcare professional examines an ISO 13485 audit checklist. The background includes lab equipment and documentation relevant to each program.

Inspections

QMSR vs ISO 13485 Inspection Program Differences

FDA Inspections Team / February 20, 2026

A business professional and a laboratory technician are inspecting a device or tool in a laboratory setting. The business professional is holding the tool, while the technician is taking notes, with a clipboard in hand, surrounded by lab equipment on a workbench.

Inspections

Top inspection Program Tools For QMSR Compliance

FDA Inspections Team / February 20, 2026

Comparison between outsourced and internal Quality Management System Requirements (QMSR) inspection programs, showing a professional woman in an office and a man in medical scrubs in a healthcare setting.

Inspections

Outsourced vs Internal QMSR Inspection Program Pros and Cons

FDA Inspections Team / February 20, 2026

A medical professional is reviewing digital data on multiple computer screens, focusing on medical imaging and patient records in a modern healthcare setting.

Inspections

How FDA’s New QMSR Inspection Process Is Changing Mock Audit Priorities for Medical Device Quality Systems

FDA Inspections Team / February 20, 2026

Inspections

Dietary Supplement Inspections After Recent FDA Salmonella and Counterfeit Alerts: What Manufacturers Must Fix Now

FDA Inspections Team / February 20, 2026

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