Published In: Medical Device and Diagnostics Industry (MD+DI)
October 10, 2023
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
Learn more about the authors below.
RM (NRCM), CBA (ASQ)
Biocompatibility Expert
Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...
Biocompatibility Expert
Helin spent several years as a biocompatibility expert at Nelson Labs, supporting various medical device manufacturers and regularly contributing educational content and presenting at live events.
