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
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows.
Regulatory changes in both Europe and the U.S. have created uncertainty among device makers. Read the Full Story in Medical Products Outsourcing Magazine
Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiveness. As of late 2015, FDA...
It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost...
Download this whitepaper to examine the various ways in which chemical characterization can augment and refine the biocompatibility testing process. Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about...
Meant to replace FDA’s 1995 G95 document, the new draft guidance document is the most expansive presentation of testing standards affecting the medical device industry in more than 18 years.
