
Consumer Product Biocompatibility Testing Webinar
Wednesday, May 14, 2025
This webinar will cover the chemical characterization of consumer products using extractable/leachable studies. Register to reserve your spot today!
Home » Extraction Expertise for Medical Device Chemical Characterization
Extractable studies are performed on medical devices to evaluate potential chemical release from a medical device during clinical use.
The primary guidance for medical device extractable studies is ISO 10993-18 “Chemical characterization of medical device materials within a risk management process”. In this international standard, a number of extraction study approaches are laid out, which are applied to medical devices based on the intended device use.
EAG offers advanced expertise and a risk-based approach for medical device extractable study design and execution, including the latest FDA expectations.
ISO 10993-18 provides guidance for the type of extraction study necessary for chemical characterization, based on device contact.
Wednesday, May 14, 2025
This webinar will cover the chemical characterization of consumer products using extractable/leachable studies. Register to reserve your spot today!
Developing a reliable product has many challenges due to the desire for increased capability, reduction in formfactor, and managing the supply chain.
In this webinar we will focus on Spectroscopic Ellipsometry (SE) which is a powerful analytical tool for the characterization of thin films.
EAG Scientists utilize GDMS analysis to perform Elemental Depth Profiling for chemical purity evaluations for aerospace & defense.
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