August 19, 2025 | By: Audrey P. Turley
Even small modifications to a medical device, whether materials, processes, or sterilization methods can significantly affect its biological safety. This whitepaper provides a risk-based framework, grounded in ISO 10993-1 and ISO 14971, for evaluating when and how to reassess biocompatibility after changes. Through practical case studies, Nelson Labs expert Audrey Turley shows how to balance compliance, patient safety, and efficient testing strategies.
Learn more about the author below.
RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & 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),...
