March 10, 2017
Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom...
See BlogFebruary 17, 2017
I am very excited for this new stage of Nelson Laboratories. For many years I have envisioned that the replacement of Dr. Jerry Nelson would be more than just a single person. The replacement needed to be a small group...
See BlogNovember 22, 2016
The document could have a significant impact on the testing regimen for implant device manufacturers. The U.S. Food and Drug Administration (FDA) released a new guidance document titled “Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for...
See BlogMarch 10, 2016
3D printing, nanotechnology, and mHealth could potentially rewrite the rules of medical device testing. Read Full Story
See BlogFebruary 24, 2016
Device manufacturers want more sterilization options at lower costs with no clinical concerns. Nelson Labs senior scientist and consulting manager, Martell Winters, weighs in regarding new versions of tissue products and new combination products that often require something “out of...
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