Header Artwork
Header Artwork

Video Gallery

Video Gallery

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)
Biocompatibility Expert

Audrey Turley has 20 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...