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
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.
According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.” Based on the...
While you may not want to think of the words “worst case” relating to your product, these words are critical in designing a chemical-characterization study and assessing those results in a toxicological-risk assessment. This blog post looks at general concepts...
Register HERE for the three-day live webinar series “How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance” presented by Nelson Laboratories’ experts: Thor Rollins, Sarah Campbell, and Audrey Turley. This three-day webinar will incorporate the new US FDA...
