Articles by n8n Publisher

5 Critical Strategies to Reduce Medical Device Recall Risk in 2024

5 Critical Strategies to Reduce Medical Device Recall Risk in 2024

By n8n Publisher |

Medical device recalls jumped 10.8% in 2024. Learn five evidence-based strategies to minimize recall risk…

Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices

Understanding Medical Device Compliance: Key Regulatory Updates and Industry Best Practices

By n8n Publisher |

Explore the current medical device regulatory landscape and discover essential compliance strategies that manufacturers need…

Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know

Fast Company Spotlights Critical Gaps in Medical Device Recall Process: What Manufacturers Need to Know

By n8n Publisher |

Fast Company highlights critical gaps in medical device recall processes, emphasizing the need for manufacturers…

FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know

FDA Expands Early Alert Pilot Program: What Medical Device Manufacturers Need to Know

By n8n Publisher |

FDA expands Early Alert pilot program beyond initial five device categories, creating new compliance requirements…

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

High-Risk Medical Device Recalls of 2024: Legal Consequences and Compliance Lessons

By n8n Publisher |

Major 2024 medical device recalls including BioZorb, Cartiva, and Impella have triggered extensive litigation, revealing…

FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers

FDA Issues Class I Recall for Q’Apel Medical Aspiration System: Critical Compliance Lessons for Device Manufacturers

By n8n Publisher |

FDA upgrades Q'Apel Medical's aspiration system recall to Class I status, affecting 1,617 units. Learn…

Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers

Medtronic Pipeline Vantage 027 Urgent Recall: Critical Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

Medtronic's urgent Pipeline Vantage 027 recall offers critical compliance lessons for medical device manufacturers on…

FDA Updates Medline Fluid Delivery Set Alert: Key Lessons for Medical Device Manufacturers

FDA Updates Medline Fluid Delivery Set Alert: Key Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA updates Medline fluid delivery set alert as part of Communications Pilot program. Key compliance…

New Congressional Bill Could Transform Medical Device Recall Communications for Manufacturers

New Congressional Bill Could Transform Medical Device Recall Communications for Manufacturers

By n8n Publisher |

New bipartisan legislation could require manufacturers to use electronic recall formats and provide enhanced patient…

FDA Expands Medical Device Recall Alert Program: What Manufacturers Need to Know

FDA Expands Medical Device Recall Alert Program: What Manufacturers Need to Know

By n8n Publisher |

FDA expands its medical device recall alert program to all devices after issuing 19 alerts…

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