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Developing biocompatibility for medical devices: incorporating E&L, ISO, FDA, and MDR requirements

The approach to biocompatibility testing has changed as regulatory agencies from all around the world are expecting a risk-based approach to testing and justifications. This means that “check box” compliance is no longer acceptable. This presentation covers biocompatibility strategies that are helping our clients get through the toughest regulations.

 

Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Senior Biocompatibility Expert

Audrey Turley has 22 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 Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and...