Articles by n8n Publisher

FDA Issues Early Alert for Baxter Infusion Pump Software Defect: What Manufacturers Must Know

FDA Issues Early Alert for Baxter Infusion Pump Software Defect: What Manufacturers Must Know

By n8n Publisher |

FDA's early alert on Baxter infusion pump software defect signals new regulatory approach. Learn compliance…

Boston Scientific Defibrillation Lead Alert: Key Compliance Lessons for Medical Device Manufacturers

Boston Scientific Defibrillation Lead Alert: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA's Boston Scientific defibrillation lead alert highlights critical post-market surveillance and communication requirements for medical…

FDA Early Alerts: What Medical Device Manufacturers Need to Know About Accelerated Safety Communications

FDA Early Alerts: What Medical Device Manufacturers Need to Know About Accelerated Safety Communications

By n8n Publisher |

FDA Early Alerts expedite safety communications for high-risk medical device issues. Learn how manufacturers can…

FDA Issues Updated Alert for BD Infusion Set Performance Issues: What Manufacturers Need to Know

FDA Issues Updated Alert for BD Infusion Set Performance Issues: What Manufacturers Need to Know

By n8n Publisher |

FDA updates BD infusion set alert as part of enhanced recall communication pilot. Learn key…

Understanding Medical Device Recalls: A Complete Guide for Manufacturers

Understanding Medical Device Recalls: A Complete Guide for Manufacturers

By n8n Publisher |

Learn the three classes of medical device recalls, voluntary vs mandated processes, and essential compliance…

FDA Early Alert: Baxter Infusion Pump Issue Highlights New Recall Communication Strategy

FDA Early Alert: Baxter Infusion Pump Issue Highlights New Recall Communication Strategy

By n8n Publisher |

FDA issues early alert for Baxter infusion pump as part of new communication pilot program.…

FDA Updates Bard Peripheral Atherectomy Catheter Alert: Key Compliance Lessons for Medical Device Manufacturers

FDA Updates Bard Peripheral Atherectomy Catheter Alert: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA updates Bard atherectomy catheter alert under new Communications Pilot program, highlighting key compliance requirements…

BD Infusion Set Performance Alert: Critical Compliance Lessons for Medical Device Manufacturers

BD Infusion Set Performance Alert: Critical Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

BD's infusion set alert highlights FDA's enhanced recall communication pilot. Learn critical compliance lessons and…

Olympus Recalls ViziShot 2 FLEX EBUS-TBNA Needles: Critical Component Detachment Risk

Olympus Recalls ViziShot 2 FLEX EBUS-TBNA Needles: Critical Component Detachment Risk

By n8n Publisher |

Olympus recalls ViziShot 2 FLEX needles due to component detachment risks. Critical compliance lessons for…

FDA Alert Update: Boston Scientific Defibrillation Lead Issue Highlights Critical Recall Communication Changes

FDA Alert Update: Boston Scientific Defibrillation Lead Issue Highlights Critical Recall Communication Changes

By n8n Publisher |

FDA's updated alert on Boston Scientific defibrillation leads showcases new recall communication standards that will…

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