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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

How to Address Regulatory Change in Your Current Biocompatibility Program

Published Date: August 23, 2018

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.

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...

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