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
As with all projects, the planning phase is one of the more crucial elements to a successful outcome. In the same light, a biological evaluation plan (or BEP as we like to call it) is one of the core pieces...
This whitepaper is a result of a discussion led by the authors as part of Veranex’s Biocompatibility Coffee Break in February 2024. It includes the critical industry questions that arose during the discussion. Download the PDF below. Learn about the...
This article by biocompatibility experts Helin Räägel, PhD, and Audrey Turley discusses the most recent FDA guidance on biological evaluations of medical devices per ISO 10993-1, highlighting the new guidance on intact skin contact. Read the Full Article in MD+DI...
This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1. Read the Full Article in MD+DI Learn more about the authors below.
Per- and polyfluoroalkyl substances, or PFAS, are chemicals that have been used in industry and consumer products for many years. A couple examples are medical device coatings and microwave popcorn bags. In this article published by Medical Device and Diagnostics...
