Quality, Safety, Biocompatibility & Regulatory Compliance for Drugs, Biologics, and Medical Devices
Eurofins EAG Laboratories will present at the Extractables & Leachables East Summit, April 23-24, 2025, in Philadelphia PA.
Dr. Casey Chamberlain, Manager, Analytical Chemistry, for Medical Device Testing at Eurofins EAG Laboratories will present:
Presentation: Collection and Interpretation of Medical Device Extractables Data in the Modern Era
Abstract: Proper collection and interpretation of extractable data are critical to ensure the output of a chemical characterization study accurately reflects the potential patient exposome resulting from a medical device. However, due to lack of defined expectation from both regulatory bodies and ISO 10993-18 regarding data handling, there is currently a spectrum of approaches that exists throughout the industry, many which are insufficient to adequately capture the extractable profile. In this presentation, we will cover three pillars of state-of-the-art chemical characterization data analysis: data deconvolution, high-resolution mass spectrometry, and reference material databases. Each of these items will be discussed with respect to the essential information they provide, along with the chemical insights which are lost in an analytical platform lacking these tools.
Dr. Saheel Bhana, Regional Sales Manager for Medical Device Testing, will host a table exhibit at the Summit. Contact us to connect with Dr. Chamberlain or Dr. Bhana or visit our medical device webpage to learn more about our testing solutions.
Visit the link below to see the event schedule. We hope to see you there!
Dr. Casey Chamberlain presenting at the Extractables & Leachables West Summit in 2024.
Eurofins EAG Laboratories, a global leader in materials testing services, is expanding its advanced microscopy capabilities with a new 6,800 square-foot laboratory in Phoenix, AZ.
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