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toxicological risk assessment

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Industry-Leading Medical Device Consulting Firm

Toxicological risk assessment is an essential part of evaluating the safety of medical devices. Paracelsus, a renowned physician, alchemist, and astrologer of the German Renaissance, is credited with the principle that "all things are poison and nothing is without poison; only the dose makes a thing not a poison." This principle is now the foundation of modern toxicology. The biological evaluation of medical devices requires establishing acceptable limits for leachable substances, as specified in ISO 10993-17. Regulatory agencies worldwide require a comprehensive toxicological risk assessment for most device submissions.

Expert Services

JL Tox Consulting specializes in toxicological risk assessment of medical devices. Our company offers many services, including calculating safe and acceptable limits, QSAR analysis, toxicity assessments, and read-across approaches. JL Tox Consulting can provide expert opinion papers, rationales, and justifications to support a biocompatibility project.

Toxicity assessment is a critical component of evaluating the safety of medical devices, and JL Tox Consulting has the expertise and experience to help medical device manufacturers navigate this complex process. From simple manufacturing changes to full extractables studies, our company can provide various services to support biocompatibility projects. With a focus on toxicological risk assessment, JL Tox Consulting can help ensure medical devices are safe for use by patients while also meeting regulatory requirements.

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