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
Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during...
In the previous two posts, the biocompatibility of 3D printed devices was discussed with consideration for the possible compounds added to the raw materials for workability and the polymer precursors and byproducts associated with photopolymerized structures. In both of these...
Nelson Laboratories will be exhibiting at the BIOMEDevice Boston show, March 26-27, 2014, at the Boston Convention & Exhibition Center in booth #528. Presentation: Process Validations for Newly Manufactured Devices – Is Your New Device Clean? During the two-day conference...
Agenda: Alexa Tatarian will present on measuring the cleanliness (not sterility) of newly manufactured medical devices at the 2014 MD&M West Conference. Alexa is a Study Director at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include: Industry...
Nelson Laboratories recently began providing Material Characterization with Extractable and Leachable testing services to help medical device manufacturers demonstrate that their products are safe and comply with government regulations. This testing can provide a significant reduction of cost and time...
