Importance of Accurate Chemical Characterization of Medical Devices

Importance of Accurate Chemical Characterization of Medical Devices

Duration - 37 Minutes

Price - INR-2000 / USD-60
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About the course

Chemical characterization of medical devices, involving the identification, quantification, and subsequent toxicological risk assessment of E&L compounds, is becoming increasingly accepted by regulatory agencies to assess the biocompatibility of medical devices. The proper implementation of this approach requires an accurate assessment of the E&L compounds that may be released from the device. This presentation will illustrate the importance of accurate chemical characterization of medical devices from a toxicological perspective and will underscore the need for chemists and toxicologists to work collaboratively to assess the potential risk posed by patient exposure to E&L compounds released from medical device materials. In addition, recommendations will be provided to help ensure that the chemical characterization of the medical device is conducted according to the current expectations of regulatory agencies.

Speaker Profile

Ron Brown

Risk Science Consortium and Former FDA

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