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
FDA announced new Office of Science and Engineering Laboratories (OSEL) Research Programs webpages. These webpages allow users to research by Clinical Area or by Special Topics. A few examples of searchable Clinical Areas are: Orthopedics, In Vitro Diagnostics (IVD), and...
FDA recently released an updated guidance document to clarify regulatory requirements for gowns. This new guidance impacts manufacturers that currently sell gowns as well as manufacturers that intend to market gowns in the future. The guidance clarifies what types of...
Recently the US FDA issued a safety notice on Lubricious Coating Separation from Intravascular Medical Devices. The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough...
The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...
Planning your BIOMEDevice conference schedule? Be sure to leave room for Nelson Laboratories, Inc. Nelson Labs will be offering a full schedule of biocompatibility focused lectures at BIOMEDevice San Jose, December 3 – 4, 2014, while also exhibiting in booth...
