What has FDA cited under ISO 13485?

1 DSRV article cite ISO 13485. Enforcement cases behind them: CDRH first-four-months QMSR inspection data under FDA Compliance Program 7382.850, Inspection of Medical Device Manufacturers, presented by CDRH Associate Director Keisha Thomas at the RAPS Quality Conference, Baltimore, June 10, 2026. Inspection exposure across them: 1 high.

What does DSRV recommend for ISO 13485?

From the newest article (Four Months Under QMSR: Risk Management Is FDA's Top Citation): FDA is not grading the risk file; it is checking whether each documented control is visible in floor-level records like environmental monitoring, supplier qualification, and training history, and ISO 13485 certification does not answer that question. DSRV is decision support, not legal advice; verify against the official source each article names.

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ISO 13485

Every DSRV article whose Regulatory Snapshot cites ISO 13485: the enforcement case behind it, the inspection exposure it created, and what the desk would do about it.

Inspection exposure across the set

What has FDA cited under ISO 13485?: 1 DSRV article cite ISO 13485. Enforcement cases behind them: CDRH first-four-months QMSR inspection data under FDA Compliance Program 7382.850, Inspection of Medical Device Manufacturers, presented by CDRH Associate Director Keisha Thomas at the RAPS Quality Conference, Baltimore, June 10, 2026. Inspection exposure across them: 1 high.
What does DSRV recommend for ISO 13485?: From the newest article (Four Months Under QMSR: Risk Management Is FDA's Top Citation): FDA is not grading the risk file; it is checking whether each documented control is visible in floor-level records like environmental monitoring, supplier qualification, and training history, and ISO 13485 certification does not answer that question. DSRV is decision support, not legal advice; verify against the official source each article names.

June 20265 min readHigh exposurecited as a tag
Four Months Under QMSR: Risk Management Is FDA's Top Citation
CDRH's first QMSR inspection data shows NAI falling to 48.8% in the framework's first four months. The top finding is risk management integration. Firms document their risk controls but cannot show they built them. The pattern pharma teams have watched in CAPA citations for years has arrived in the device sector under a new regulatory name.
Case
CDRH first-four-months QMSR inspection data under FDA Compliance Program 7382.850, Inspection of Medical Device Manufacturers, presented by CDRH Associate Director Keisha Thomas at the RAPS Quality Conference, Baltimore, June 10, 2026.
DSRV take
FDA is not grading the risk file; it is checking whether each documented control is visible in floor-level records like environmental monitoring, supplier qualification, and training history, and ISO 13485 certification does not answer that question.

Address this risk

Pressure-test your evidence before an inspector reads it

Bring the document that has to hold up under ISO 13485. DSRV maps the evidence, names the gaps, and routes judgment calls to human review. Controlled intake, no public file upload.

Apply for the Stability Pilot Ask The Vault about ISO 13485

Regulatory intelligence and interpretation, not legal advice. Verify against the official FDA or ICH source each article names.