Electrosurgical Pen FDA / ISO Biocompatibility Study Testing
Project Description
United States Preclinical Contract Research Organization needed for FDA / ISO biocompatibility Study testing of ex vivo porcine belly skin damage from an electrosurgical pen per FDA/ISO guidelines.
The FDA recommends Thermal Effects on Tissue - For each mode and each representative active component or electrode, you should provide a measurement (under magnification) of the size (length, width, and depth) of the thermal damage zone, i.e., coagulation necrosis.
This testing may be performed on ex vivo animal tissue. FDA's preference is porcine belly skin but not porcine muscle or organs.
A Histology Report will be required.
Project Information
Number:23-02617
Industry:Medical Devices
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Other medical devices laboratory services.
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