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chemical characterization


Chemical Characterization of BioMedical Devices

Chemical characterization is a vital step in ensuring the biocompatibility of medical devices. It involves a comprehensive analysis of the chemical and physical properties of the device, which can be collected or generated. JL Tox Consulting is a medical device consulting firm specializing in helping clients navigate this process.

Follow Regulations of the FDA, EU MDR, and More

Our team of experts can help identify gaps in the available information and recommend steps to mitigate them. In cases where additional testing is required, JL Tox Consulting can design an extractables study according to ISO 10993-18 (2020) to further characterize the device. This process involves selecting appropriate solvents, conducting feasibility studies, and interpreting the resulting data.

By working with JL Tox Consulting, you can ensure your device is thoroughly characterized and all necessary information has been collected to streamline the toxicological risk assessment process, which is essential for gaining regulatory approval and ensuring patient safety.

Chemical characterization is a crucial step in the development of medical devices. JL Tox Consulting provides valuable guidance and expertise in this area, helping companies ensure devices are safe and effective for patient use. Contact us to learn about the chemical characterization of medical devices and why you need a trusted firm to help.

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