Articles by n8n Publisher

New Congressional Legislation Aims to Strengthen Medical Device Recall Process: What Manufacturers Need to Know

New Congressional Legislation Aims to Strengthen Medical Device Recall Process: What Manufacturers Need to Know

By n8n Publisher |

New bipartisan legislation aims to strengthen medical device recall processes, requiring manufacturers to prepare for…

Olympus Expands EBUS-TBNA Needle Recall: Critical Component Failure Risks for Medical Device Manufacturers

Olympus Expands EBUS-TBNA Needle Recall: Critical Component Failure Risks for Medical Device Manufacturers

By n8n Publisher |

Olympus expands EBUS-TBNA needle recall due to component ejection risks. Learn compliance implications and actionable…

Congressional Leaders Target Medical Device Recall Reform: What Manufacturers Need to Know

Congressional Leaders Target Medical Device Recall Reform: What Manufacturers Need to Know

By n8n Publisher |

Congressional leaders target medical device recall reform. Learn what manufacturers need to know about potential…

Abbott’s FreeStyle Libre 3 Correction: Critical Lessons for CGM Manufacturers on Post-Market Surveillance

Abbott’s FreeStyle Libre 3 Correction: Critical Lessons for CGM Manufacturers on Post-Market Surveillance

By n8n Publisher |

Abbott's voluntary FreeStyle Libre 3 correction offers critical lessons for medical device manufacturers on post-market…

GAO Report Highlights FDA Medical Device Oversight Gaps: Key Compliance Implications for Manufacturers

GAO Report Highlights FDA Medical Device Oversight Gaps: Key Compliance Implications for Manufacturers

By n8n Publisher |

GAO report criticizes FDA medical device oversight. Learn key compliance implications and proactive strategies for…

Medical Device Recalls Surge to Four-Year High in 2024: Critical Compliance Insights for Manufacturers

Medical Device Recalls Surge to Four-Year High in 2024: Critical Compliance Insights for Manufacturers

By n8n Publisher |

Medical device recalls hit a four-year high in 2024, creating critical compliance challenges. Learn key…

4 Essential Steps to Strengthen Medical Device Recall Tracking and Compliance

4 Essential Steps to Strengthen Medical Device Recall Tracking and Compliance

By n8n Publisher |

Learn the four essential steps medical device manufacturers must take to strengthen recall tracking systems…

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

By n8n Publisher |

Medtronic's Bravo CF Capsule recall offers critical lessons for manufacturers on component failures, post-market surveillance,…

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

By n8n Publisher |

FDA announces Calyxo CVAC Aspiration System correction under new Communications Pilot program, highlighting key IFU…

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

By n8n Publisher |

Conavi's Novasight Hybrid Catheter recall highlights critical post-market surveillance gaps. Learn compliance actions for intravascular…

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