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Alert: Ventilator Systems Risk in Neonatal Tidal Volume Delivery

by MDP Staff | Jul 24, 2025 | Alerts-Device, Corrections, Industry News, Med-Devices, Safety

Updated Use Instructions for Maquet Servo Ventilator Systems Risk in Neonatal Tidal Volume Delivery Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Maquet Servo Ventilator SystemsSource: FDA...

Urgent Recall of Codman Disposable Perforators

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Device, Class I Recalls, Product Recalls, Product Safety, Safety

Cranial Drill Urgent Recall Alert Serious safety risks Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of...

FDA Cracks Down on Insightra Medical

by MDP Staff | Jul 16, 2025 | Alerts, Cardiovascular, Device Warning Letters, FDA Enforcement, FDA Public Information, FDA Warning letters, Industry News, Med-Devices, QSR, Safety

FDA Cracks Down on Insightra Medical Unapproved use and serious quality violations found Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Cites a Number of Serious Violations In a...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

by Devices and Pharma | Jul 10, 2025 | Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Products_Devices, Safety, US-FDA

AirLife/Vyaire Infant Breathing Systems Recall Potential for risk of disconnection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall AirLife and manufacturer Vyaire are recalling...

How Unsafe Medical Devices Can Slip Through the Cracks

by Devices and Pharma | May 16, 2025 | Consumer Information, Industry Information, Med-Devices, MedWatch-System, Product Safety, Quality Information, Safety, US-FDA

Medical Devices Deemed Unsafe Overseas but Sold in the US A Global Gap in Patient Protection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Healthcare professionals and the device industry share...

Study Reveals Delays in Medical Device Adverse Event Reporting

by Devices and Pharma | May 16, 2025 | Industry Information, Med-Devices, Product Safety, Regulatory_Info, Safety

Device Manufacturers Often Delay Reporting Adverse Events Four major manufacturers account for nearly half of late reports Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Healthcare professionals...
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