At Toxway, we offer comprehensive Toxicological Risk Assessments (TRA) of Extractables and Leachables (E&L) to ensure the utmost safety and efficacy of materials used in medical devices. Our TRA services are conducted in strict adherence to ISO 10993-17 guidelines, which provide a robust framework for evaluating the chemical substances that may migrate from device materials during normal use.

Our process begins with an exhaustive extraction study, where we simulate real-world conditions to identify and quantify potential extractables and leachables from the device materials. This includes rigorous testing under various conditions to mimic the intended use of the device. Once identified, these substances are subjected to a thorough toxicological evaluation to assess their potential risks to patient health.

We analyze the toxicological profiles of these extractables and leachables, considering factors such as their chemical nature, concentration, and potential biological impact. This detailed analysis enables us to determine if any of these substances pose a significant risk to patients and to what extent they might affect the overall safety and biocompatibility of the device.

Our TRA not only confirms compliance with regulatory standards but also helps mitigate risks associated with material migration. By providing a clear understanding of potential safety concerns, we help ensure that your medical device meets the highest standards of biocompatibility and regulatory compliance. This thorough assessment is crucial for securing regulatory approvals, enhancing product reliability, and ensuring patient safety throughout the lifecycle of your medical device.

For more information about our services or to request a consultation, contact us at info@toxway.com