Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
The FDA is alerting healthcare providers about a potential high-risk issue with certain Baxter Healthcare Solution Sets with Duo-Vent Spikes. Baxter has issued a recall for several lots of these ...
Security is strengthened by reducing the attack surface, but this also makes the submission process far more user-friendly.
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
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