The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Posted in Printing Services by MDDI Staff on May 24, 2016 A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices. On May 10, 2016, FDA released a leapfrog guidance document on the...
With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...
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...
Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and...
The business of getting medical devices to market is a complex web of variables including the laboratory testing we do at Nelson Labs. We know that an intimate knowledge of regulatory behavior, draft guidance and guidance documents can significantly improve...
