Build Clear, Reviewer-Ready Chemical Characterization forYour Biocompatibility File
Strong biocompatibility submissions start with well-structured chemistry. We prepare the plan, reporting thresholds, and result tables that your toxicologist needs to move confidently into the TRA. Testing remains with your chosen lab.
The Red Flags Reviewers Notice First
- You’re planning an extractables & leachables (E&L) study and need the right test plan.
- You must set or justify your Analytical Evaluation Threshold (AET) and uncertainty factor.
- You need to re-package old E&L lab reports in a clean, reviewer-friendly format.
- You want a traceable chemistry → toxicology handoff for the TRA.
- You need chemistry that aligns with ISO 10993-18 and FDA’s risk-based expectations.
Why This Matters Now
Regulators increasingly expect the chemistry package to come first. FDA’s biocompatibility guidance points manufacturers toward ISO 10993-1 and requires that chemical characterization be planned and justified according to ISO 10993-18 as part of a risk-based evaluation. Well-structured chemistry prevents friction downstream during toxicological review.
ISO 10993-18 also defines how to set the Analytical Evaluation Threshold (AET)—including the method uncertainty factor clarified in the 2022 amendment. Reviewers expect to see both the math and the rationale clearly stated.
Finally, FDA’s TEEM tool incorporates the 2023 ISO 10993-17 logic for exposure and margin-of-safety calculations. That means clean chemistry inputs accelerate decision-making in the TRA and reduce questions.
From Chemistry to Clarity
We plan, review, and package the chemistry components of biocompatibility so they flow naturally into the toxicological assessment. No lab testing—your lab runs the study; we guide the plan and document the results.
Plan the study: We outline the extraction conditions and analytical techniques appropriate for your device. Your lab executes the plan.
Set the reporting rules: We derive and justify the AET and its uncertainty factor so only meaningful signals become reportables.
Review results: We check identifications, highlight unknowns, and determine what truly needs to feed toxicology.
Package for the TRA: We deliver clean ID/Quant tables and a traceability matrix aligned with ISO 10993-17 logic.
Your Complete Chemical Characterization Package
Everything you need for a clean, traceable Chemistry Package:
Why Teams Trust Our Chemistry 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.
Chemistry plans aligned with ISO 10993-18 and FDA expectations.
Clear AET and uncertainty factor rationale with traceable calculations.
Reviewer-friendly wording that reduces back-and-forth.
Seamless handoff from chemistry → toxicology → TRA.
Ability to re-structure legacy lab reports into modern, compliant formats.
Strengthen Your Submission With Clean, Standard-Aligned Chemistry
Our team helps you plan and document the chemistry so your toxicologist can reach conclusions quickly and confidently—strengthening your submission, reducing questions, and improving regulatory predictability.
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