by MDP Staff | Jul 24, 2025 | EU MDR, FDA Reports, Global-RA, Industry Information, MDR - Medical Device Report, Med-Devices, US-FDA
Global Medical Device Reporting and Vigilance Reporting serious safety risks Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact International Medical Device Reporting Medical Device Reporting and...
by MDP Staff | Jul 24, 2025 | FDA Reports, Industry Information, MDR - Medical Device Report, Quality system, Safety, US-FDA
FDA Medical Device Reporting Know when and how to file an MDR Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact U.S. FDA Medical Device Reporting What is 21 CFR Part 803 (Medical Device...
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...
by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, FDA_Innovation, Product Recalls, US-FDA
FDA Pilot Program Updates Recall Reporting The goal is to improve early communication Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Recall Communication “Early Alerts” Note: This summary is...
by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Reports
BD Alaris Pump Module model 8100 Performance can worsen when connected to other perfusion sets Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall (Correction) The FDA has issued an...
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...
