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
Sample representativeness and quantity determination for test articles have been discussed in my previous posts. Continuing on the topic of what to consider when performing biological testing, this post will cover the extraction conditions to be applied for testing. Extraction...
At this year’s MD&M West trade show, Nicholas Christiano, Global Segment Leader for Biological Safety at Nelson Laboratories, presented on updates to the new revision of ISO 10993-1, the cornerstone standard guiding biocompatibility assessments for medical devices. ...
In my previous blog post I discussed sample representativeness and provided recommendations on how test articles should be prepared, outlining details that may be overlooked in the process. With various considerations that need to be accounted for, it is difficult...
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.
