March 23, 2016
Effective March 21, 2016, FDA released updates to the guidance Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Specifically, the document addresses an...
See BlogFebruary 24, 2016
Three-dimensional (3-D) printed medical devices are becoming more common in the industry. Subtractive manufacturing, the more traditional method for a milled device, consists of starting with a block of material and removing different parts of the material in order to...
See BlogOctober 4, 2013
Nelson Labs’ bacterial endotoxin (BET) test is now fully automated! As of August 2013, the new paperless system generates final reports directly from raw data entered into the endotoxin testing software. As soon as the raw data and final report...
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