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Avanos Recalls Ballard Closed Suction Systems

by Bruce Waldon | Jul 10, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, MedWatch-System, Product Recalls, US-FDA

Avanos Recalls Ballard Closed Suction Systems Due to sterilization failure Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact May result in non-sterile devices Avanos Medical, Inc. is recalling its...

FDA Alert: Abiomed Impella Blood Pump Controller

by Bruce Waldon | Jul 8, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Abiomed Impella Blood Pump Urgent Recall Controller may fail to detect the Impella device Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella blood pump controllers...

FDA Alert: Baxter Recalls Spectrum Infusion Pumps

by Bruce Waldon | Jul 4, 2025 | Alerts, Alerts-Device, Class I Recalls, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Baxter Recalls Spectrum Infusion Pumps Software error could result in dangerous dosing Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Baxter Spectrum Infusion Pump Alert Date: July...

How Unsafe Medical Devices Can Slip Through the Cracks

by Bruce Waldon | 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 Bruce Waldon | 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...

A QSR to QMSR Transition Strategy

by Bruce Waldon | May 14, 2025 | Industry Information, ISO 13485, Med-Devices, Product Quality, QMSR, Strategy

QSR-to-QMSR Implementation Strategy US manufacturers not certified to ISO 13485:2016 Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers QMSR Implementation Strategy for U.S....
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