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LIVE WEBINAR

Biocompatibility Testing: What You Need to Know

June 4, 2024

4:00 pm ET

Audrey P. Turley, Katrina Hurst, PhD and Lucas Ma

When it comes to biocompatibility testing on medical devices, there are many aspects that have to be considered not only in determining the applicable tests, but the condition of the samples and how they are prepared for testing. Failure to provide clinically representative samples or sufficient instructions for sample preparation may lead to inaccurate results or test failures that otherwise may have been avoided. In such cases the option would be to perform a retest, which is both costly and time-consuming. This webinar will help you better partner with your laboratory to ensure successful completion of your biocompatibility testing.

In this webinar, we will specifically address:

  • Preparing and sending samples for best results.
  • How to prevent issues in testing before they happen.
  • How to address issues with testing if they happen.
  • When should additional testing be pursued.

Learn more about the presenters below.

Audrey Turley

Audrey Turley

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),...

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Katrina Hurst, PhD

Biocompatibility Expert

Katrina has extensive expertise writing biological evaluations and assessments for regulatory submissions. She also has over ten years of experience in scientific research, over four years of medical device experience managing validation work for regulatory acceptance, and is currently working as a biocompatibility expert in the technical consulting group at Nelson Labs, giving guidance and recommendations for biocompatibility assessments targeted for regulatory submissions all over the world. She received her PhD in physiology and developmental biology from Brigham Young University.

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Lucas Ma

Biocompatibility Expert

Lucas Ma has over 10 years of experience in the biocompatibility field. Having started his career in a department of two, he is accustomed to extensive biocompatibility roles. Beginning as a lab technician, Lucas gained first-hand experience on preparing medical devices for sterilization and testing. Over time he moved to an associate biocompatibility role, writing test plans, assessments, and reports for a variety of medical devices, ranging from surface-contacting to implantable devices. Eventually Lucas became the main biocompatibility lead for devices in new product development, giving him experience with FDA 510(k) and other international submissions. His industry knowledge is a great asset when working on biocompatibility evaluation plans and trouble-shooting issues that arise during testing.