Articles by n8n Publisher
Congressional Push for Electronic Medical Device Recall Reporting: What Manufacturers Need to Know
By n8n Publisher |
Senators Durbin and Schakowsky propose electronic recall reporting for medical devices. Learn what manufacturers need…
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…
Medical Device Recall Improvement Act Reintroduced: What Manufacturers Need to Know
By n8n Publisher |
New legislation could transform medical device recall communications with mandatory electronic notifications and enhanced patient…
New Congressional Bill Could Transform FDA Medical Device Recall Requirements
By n8n Publisher |
New bipartisan legislation could reshape FDA medical device recall requirements through electronic reporting and enhanced…
New Congressional Bill Proposes Major Changes to Medical Device Recall Communications
By n8n Publisher |
Congressional leaders reintroduce Medical Device Recall Improvement Act to enhance recall communications and protect patients…
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…
Olympus Bronchoscope Labeling Update: Critical Safety Lessons for Medical Device Manufacturers
By n8n Publisher |
Olympus's voluntary bronchoscope labeling update offers key compliance lessons for medical device manufacturers on post-market…
FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Lessons for Device Safety Programs
By n8n Publisher |
FDA updates alert on Nuwellis blood circuit issues as part of enhanced recall communication pilot,…
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
By n8n Publisher |
Former FDA director's perspective reveals why proactive medical device recalls demonstrate robust quality systems and…
