In this course you will learn what changes are occurring in regulatory standards, including ISO 10993, Medical Device Regulations, and FDA guidance. Then based on these changes you will learn how to keep your biocompatibility program current.
Recent regulatory changes and those in the pipeline need to be evaluated within the context of an existing biocompatibility program. You will learn how to evaluate your biocompatibility information and determine what the gaps are and your options in addressing them.
BS, RM (NRCM), CBA (ASQ)
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 by Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey also has experience performing, consulting and training on bioburden, microbial IDs, sterility and BF testing. She trains staff within the biocompatibility department and works on a company-wide live to troubleshoot problems.