We are excited to announce Eurofins EAG Laboratories will exhibit and present at MD&M West in Anaheim February 4-6, 2025, in booth number 2899.
Dr. Philip Ferko, Senior Scientist with EAG, will present in the MD&M West Center Stage at 12pm on February 4.
Presentation Title: Regulatory Update: Game-Changing FDA Guidance for Part 18 Studies
Abstract: Significant changes in the FDA interpretation of chemical characterization under ISO 10993-18 are occurring. In 2024 the FDA released the “Chemicals List for Analytical Performance” and draft guidance “Chemical Analysis for Biocompatibility Assessment of Medical Devices”. The FDA also held a Public Workshop discussing the “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices”. Clearly, the FDA is defining expectations of the Chemical Characterization programs, and the analytical testing labs must adapt to continue producing effective chemical characterization reports. This talk will discuss key changes and relevant questions to ask any analytical laboratory prior to performing chemical characterization work.
View more information about Dr. Ferko’s presentation or contact us to learn more about medical device testing solutions.
We hope to see you there!
17th November 2022
EAG has been approved as a suitable commercial laboratory to provide MIL-STD 883/750 Test Method 1018 Internal Water Vapor Content Testing for hermetically sealed electronic devices.
A device manufacturer observed defects in a lot of thermoplastic tubing. The tubing exhibited signs chemical attack or exposure to heating.
Biomedical products analyzed by EAG Laboratories include stents, catheters, balloons, implants, lens, diagnostics and more
Mechanical testing incorporates the measurement of the material’s mechanical response to an applied force or displacement
Complex oxides in energy storage, catalysis, sensor/actuation, optics, epitaxy substrates, electronics, bioceramics, structural ceramics
Auger Tutorial by EAG, in this instrumentation overview we present the history of Auger, along with details regarding analyzers and detectors
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