U.S. ISO Certified Experts Announced

 

Thor Rollins, Michelle Lee, and Audrey Turley have been accepted as U.S. experts to four working groups in the Biological Evaluation ISO Technical Committee 194: WG5 (Cytotoxicity – Thor), WG8 (Sensitization and Irritation – Michelle), WG9 (Effects on blood – Michelle), and WG6 (Genotoxicity, Carcinogenicity, and Reproductive Toxicity – Audrey). This placement allows participation in the annual ISO meetings to discuss changes to the ISO 10993 and movements surrounding the approach to biocompatibility of medical devices. These meetings have recently been closed, and only those that are nominated and accepted by the co-chair of the respective working groups are allowed to attend and participate in the international annual meeting. Meet the experts:

Thor Rollins started his career at Nelson Laboratories as the study director over cytotoxicity testing. He is familiar with the test procedure and can speak to its application to medical devices providing a deep knowledge of all the complexities that can occur in cytotoxicity testing. Thor frequently works with clients who run into issues with cytotoxicity and need help mitigating patient risk.

Michelle Lee has been highly involved in several ISO round robins over the last few years including a Hemolysis, Complement, and currently an in vitro irritation round robin. Nelson Laboratories have been the top testing laboratory involved providing input on sample type, sample preparation, and protocol development for these projects. Michelle is also working to develop an in vitro sensitization assay using 3D human tissues.

Audrey Turley was one of the key personnel in bringing the in vitro chromosomal aberration assay in-house at Nelson Laboratories. Once the test was validated, she stepped in as the study director for the next six years. Currently, Audrey is working as a technical consultant to help clients perform risk assessments to address carcinogenicity risks.

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