Biocompatibility & Toxicological Risk Assessment for
Medical Devices
Chemical characterization is only useful when it leads to a clear, defensible toxicological conclusion. We convert your chemistry results into a straightforward toxicological risk assessment that follows ISO 10993-17:2023 and fits cleanly into the ISO 10993-1 risk-management approach used by MDR and FDA reviewers.
Signs Your Company Needs a Toxicological Risk Assessment
- You have new extractables/leachables data and must conclude toxicological acceptability.
- You’re facing reviewer questions, deficiencies, or back-and-forth loops.
- You need a clear, consistent way to move from AET to exposure, and then to TI/TTC and Margin of Safety.
- You’re unsure how the 2023 revision of ISO 10993-17 changes exposure and acceptance decisions.
- Your chemistry report is long, but the acceptable/not-acceptable conclusion isn’t clear.
Why This Matters Now
ISO 10993-17 was fully revised in 2023, formalizing EEDmax (worst-case exposure), Margin of Safety (MoS), and screening/acceptance logic—methods regulators now reference directly.
At the same time, ISO 10993-18 positions chemical characterization as the first step before biological evaluation, and ISO 10993-1 reinforces a risk-based approach that uses existing evidence before any testing.
A structured narrative reduces uncertainty, avoids unnecessary testing, and limits reviewer pushback.
Discovery, Plan and Execute
A Toxicological Risk Assessment is essentially a structured way of answering one question: “Is patient exposure to these chemicals acceptable?”
To make this decision clear and defensible, we follow a step-by-step process that turns complex chemistry data into a transparent toxicological narrative.
Discovery: We review your device, how it contacts the body, and your extractables/leachables results. This helps us understand which substances matter and where to focus the assessment.
Plan: We determine which chemical findings need identification, how to estimate the patient’s possible exposure, and what health-based limits we’ll use to judge safety.
Execute: We estimate the highest amount a patient could reasonably be exposed to, compare it with toxicological limits from literature or established thresholds, and determine whether the exposure is acceptable.
Handover: You receive a transparent, reviewer-ready report that lays out the reasoning step by step: the estimated exposure, the health-based limits used, the safety margin, and the final “acceptable/not acceptable” conclusion—written in clear, defensible language.
Your Complete Toxicological Evidence Package
A a complete set of documents and calculations that translate your chemistry data into a clear, defensible toxicological conclusion.
Download the ISO 10993-1:2025 Guide
Understand what changed in the new ISO 10993-1:2025 and how the updated framework reshapes biological evaluation.
Clear before/after comparisons help your team plan testing, justify evidence, and align with MDR/FDA expectations.
Why Teams Trust Sobel’s Biocompatibility & TRA Work
Sobel supports global manufacturers with toxicological risk assessments that follow ISO 10993-1 risk logic and apply the revised ISO 10993-17/18 framework with clarity and consistency.
Our approach delivers:
Clear ISO 10993-1 biological evaluation integrated with chemistry and TRA
Exposure and acceptability decisions consistent with ISO 10993-17:2023
Traceable logic from AET → reportables → exposure → TI/TTC → MoS → conclusion
Fewer reviewer questions through transparent assumptions and rationale
Consistent toxicological reasoning across multiple devices and submissions
Structured documentation aligned with MDR, FDA, and modern reviewer workflows
Get your biocompatibility plan
Our experts translate complex chemistry into clear, confident toxicological decisions. Start now!
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