New Congressional Bill Could Transform FDA Medical Device Recall Requirements
New bipartisan legislation could reshape FDA medical device recall requirements through electronic…
New Congressional Bill Proposes Major Changes to Medical Device Recall Communications
Congressional leaders reintroduce Medical Device Recall Improvement Act to enhance recall communications…
Baxter Ventilator Recall: Critical Charging Failures Expose Risk Management Gaps
Baxter's urgent ventilator recall due to charging failures exposes critical gaps in…
Olympus Bronchoscope Labeling Update: Critical Safety Lessons for Medical Device Manufacturers
Olympus's voluntary bronchoscope labeling update offers key compliance lessons for medical device…
FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Lessons for Device Safety Programs
FDA updates alert on Nuwellis blood circuit issues as part of enhanced…
User Interface Software Errors Drive Medical Device Recalls: Critical Lessons for Manufacturers
Analysis of 2012-2015 FDA recall data reveals UI software errors as major…
