Recall

Medtronic DLP Left Heart Vent Catheter Recall: Critical Lessons for Cardiovascular Device Manufacturers

Medtronic DLP Left Heart Vent Catheter Recall: Critical Lessons for Cardiovascular Device Manufacturers

By n8n Publisher |

Medtronic's DLP Left Heart Vent Catheter recall highlights critical compliance lessons for cardiovascular device manufacturers…

Olympus Polyloop Recall: Critical Lessons for Medical Device Post-Market Surveillance

Olympus Polyloop Recall: Critical Lessons for Medical Device Post-Market Surveillance

By n8n Publisher |

Olympus's voluntary Polyloop corrective action offers critical lessons for medical device manufacturers on post-market surveillance…

GAO Report Exposes Critical FDA Staffing Gaps Affecting Medical Device Recall Oversight

GAO Report Exposes Critical FDA Staffing Gaps Affecting Medical Device Recall Oversight

By n8n Publisher |

GAO audit reveals FDA staffing shortages are delaying medical device recall oversight, forcing manufacturers to…

GAO Report Exposes Critical FDA Staffing Gaps in Medical Device Recall Oversight

GAO Report Exposes Critical FDA Staffing Gaps in Medical Device Recall Oversight

By n8n Publisher |

GAO investigation reveals FDA staffing shortages are delaying medical device recall oversight, forcing critical activities…

Baxter Ventilator Recall: Critical Charging Failures Expose Risk Management Gaps

Baxter Ventilator Recall: Critical Charging Failures Expose Risk Management Gaps

By n8n Publisher |

Baxter's urgent ventilator recall due to charging failures exposes critical gaps in risk management and…

User Interface Software Errors Drive Medical Device Recalls: Critical Lessons for Manufacturers

User Interface Software Errors Drive Medical Device Recalls: Critical Lessons for Manufacturers

By n8n Publisher |

Analysis of 2012-2015 FDA recall data reveals UI software errors as major recall driver. Learn…

Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management

Why Medical Device Recalls Can Signal a Healthy Quality System: FDA’s Perspective on Proactive Risk Management

By n8n Publisher |

Former FDA director's perspective reveals why proactive medical device recalls demonstrate robust quality systems and…

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…

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