Translating chemical and exposure data into a clear, scientifically defensible conclusion on patient safety.
A Toxicological Risk Assessment evaluates the potential health risks posed by chemical substances that may leach from a device's materials during clinical use. Our ERT and DABT-certified toxicologists identify and quantify extractable and leachable compounds and compare exposure levels against established toxicological thresholds — such as the Tolerable Intake or the Threshold of Toxicological Concern.
TRAs are a critical part of the biological evaluation process, especially for devices with prolonged or permanent tissue contact, determining whether any substance poses an unacceptable risk to the patient.
Evaluating health risk based on chemical and exposure data.
Quantifying route, frequency, and duration of patient contact.
Referencing established toxicological thresholds for each compound.
Confirming risk conclusions align with biocompatibility findings.
Compound-level data from Chemical Characterization is reviewed in full.
Route, frequency, and duration of contact are modeled against real use.
Each compound is assessed against Tolerable Intake and Margin of Safety.
A defensible risk conclusion is delivered, ready for your BER.
A defensible toxicological risk conclusion for every identified compound.
Clear pass/fail or mitigation guidance against safety thresholds.
Documentation ready for direct inclusion in your BER.
Direct access to the certified toxicologist behind the assessment.
Talk to our regulatory and scientific experts today.
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