by Devices and Pharma | 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...
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...
by Devices and Pharma | 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...
by Devices and Pharma | 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...
by Devices and Pharma | 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...
by Devices and Pharma | 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,...