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Mechanical Circulatory Support (MCS) Devices

by Bruce Waldon | Jul 10, 2025 | Cardiovascular, Implantable Devices, Industry Information, Med-Devices, Products_Devices

Mechanical Circulatory Support (MCS) Devices Product family overview Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Overview of MCS Devices Mechanical Circulatory...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

by Bruce Waldon | 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...

GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk

by Bruce Waldon | Jul 7, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Product Recalls, Products_Devices

GE HealthCare Anesthesia Systems Recall potentially life-threatening risk in Volume Control Ventilation (VCV) mode Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact GE Carestation Anesthesia...

FDA Issues Warning on Epinephrine Nasal Solutions

by Bruce Waldon | Mar 14, 2025 | Alerts, Alerts-Pharma, Consumer Information, Consumer Safety, MedWatch-System, Products_Drugs

FDA Warning: Epinephrine Nasal Solutions Threat of packaging and labeling mixups Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Left: BPI Labs’ FDA-approved Epinephrine Injection with blue lid...

EU MDR Compliance Consulting Services

by Bruce Waldon | May 27, 2024 | EU MDR, Global-RA, Industry Information, Industry News, Med-Devices, Products_Devices, Reg_Products

Ensuring Compliance with EU Medical Device Regulation (MDR) Your Partner in Navigating EU MDR Requirements Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our...

Extensions for EU MDR and IVDR Implementation

by Bruce Waldon | May 27, 2024 | EU MDR, Global-RA, Industry Information, Industry News, Med-Devices, Products_Devices, Products_IVDs, Reg_Information

Extensions for the European Union MDR and IVDR Key EU medical device regulation updates Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact Initial EU MDR and IVDR transition periods extended  In 2023,...
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