Build a Reviewer-Ready Toxicological Risk Assessment (TRA) From Your
Chemistry Results
Turn extractables and leachables data into a clear, consistent, and defensible conclusion about patient safety — aligned with the latest ISO rules and FDA expectations.
When These Situations Happen, It’s Time for a TRA
- You received chemical characterization results and must decide whether patient exposure is acceptable.
- You need to answer reviewer questions about exposure calculations, toxicology limits, or acceptance logic.
- You want consistent decisions across multiple devices and submissions.
- You need to align your reasoning with the latest 2023 toxicological risk assessment approach.
- You want to avoid unnecessary testing and rely on evidence-based exposure and margin-of-safety logic.
Why This Matters Now
Recent regulatory updates changed how toxicological reasoning is expected to be demonstrated.
The 2023 edition of the ISO 10993-17 standard now defines how to estimate conservative patient exposure and how to decide acceptability so that all dossiers speak the same mathematical and logical language.
At the same time, the FDA emphasizes risk-based decision-making and points manufacturers toward consistent use of the ISO 10993-1 process rather than automatic testing. The agency even provides a public exposure and margin-of-safety calculator aligned with the new methodology — a strong signal of what reviewers expect.
This means your toxicological rationale must follow a clear, transparent, and defensible structure.
How We Turn Your Chemistry Data Into a Clear Conclusion
We take your laboratory chemistry data and convert it into a reviewer-ready risk assessment rooted in transparency and scientific logic:
We start from your chemical results and identify which substances can come out of the device and in what amounts.
We calculate a conservative patient exposure based on the latest 2023 rules for medical device toxicological assessment.
We compare exposure to health-based limits, using tolerable intake values when available or applying the threshold of toxicological concern when needed.
We write a clear, defensible conclusion inside a risk-based framework that regulators recognize, answering the core question: “Is this exposure acceptable?
Everything You Need for a Defensible TRA
Your Toxicological Risk Assessment package includes:
Why Teams Trust Our Assessments
Sobel is an international regulatory consultancy supporting manufacturers with evidence-based, reviewer-ready submissions for medical devices, IVDs, and cosmetics across the U.S., EU, Brazil, and other major markets.
Decisions are consistent across your entire device portfolio.
Exposure and acceptance logic aligned with ISO 10993-17:2023.
Risk-based justification that reflects FDA’s current expectations.
Reviewer-oriented writing style built to reduce back-and-forth.
Ability to disposition low-concern substances early, reducing unnecessary analysis.
Get a clear, defensible Toxicological Risk Assessment aligned with the latest global expectations.
Our team helps you turn complex chemical results into a transparent acceptance rationale — accelerating submissions, reducing questions, and strengthening your overall regulatory strategy.
Contact Us
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