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), and genotoxicity (Ames and chromosome aberration). She also has experience performing, consulting, and training on bioburden, microbial IDs, sterility and bacteriostasis/fungistasis testing. She worked on the teams at Nelson Labs responsible for the development of the in vitro mammalian chromosomal aberration assay as well as the in vitro irritation assay for medical devices.
Audrey has several years of experience consulting with clients to support biocompatibility in device submissions around the globe through writing risk assessments, biological evaluation plans (BEPs), biological evaluation reports (BERs), and gap analyses as well as in person discussions with regulatory agencies and on-site customized company trainings.
Currently Audrey leads the Expert Advisory Team at Nelson Labs, which provides subject matter expertise (SME) support for all of the testing performed at Nelson Labs. She is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI) as well as the International Organization for Standardization (ISO).