When this applies
Devices where chemistry testing has not been done and may not be warranted — limited-contact devices, well-characterised materials with supplier formulation data, early-stage programmes, and legacy devices being brought under ISO 10993-1:2025 — and any situation where a documented toxicological rationale is needed before deciding whether extractables testing is justified at all.
When to commission it
Before commissioning chemistry, as the cheapest way to find out whether it is needed; or in place of chemistry where a worst-case theoretical assessment is sufficient for the contact category. Allow five weeks from receipt of all inputs — complete formulations and SDS for every material and process chemical are what set the pace.
What you receive
A toxicological risk assessment in Groenakker’s template or yours covering: evaluation of every provided material and process chemical; theoretical patient exposure doses derived from formulations and SDS assuming worst-case release; screening against US and EU restricted-substance regulations; grouping into chemical families; and comparison of each exposure dose with the ISO 10993-17 toxicological screening limit, with the residual uncertainty stated explicitly. Signed by a DABT board-certified toxicologist.
What it does not cover
Constituents above the screening limit need the per-constituent TI and EEDmax derivation (GRK-2004), quoted separately. The assessment is only as complete as the formulation data behind it — undisclosed or proprietary ingredients are a gap it will name, and where worst-case assumptions give an unacceptable margin, extractables testing is usually the answer. Urgent requests — delivery in fewer than three business days from receipt — are billed at the standard hourly rate in addition to the base price, and work outside standard business hours (Monday to Friday, 8:00 AM to 5:00 PM ET, excluding observed holidays) at two times the hourly rate; both are subject to availability and confirmed in writing before work starts.
Method
A toxicological risk assessment to ISO 10993-17:2023 built from material formulations, safety data sheets and manufacturing contact substances, for devices with no extractables and leachables data. A Groenakker toxicologist compiles the material formulations, SDS and the manufacturing contact substances — lubricants, processing aids, detergents, fixturing, gloves and similar; calculates theoretical exposure doses from composition, device mass and contact duration assuming complete release; screens the constituents against regulatory lists; groups them; and compares each with the toxicological screening limit. The report is reviewed and signed by a DABT board-certified toxicologist.
Who does the work
In-house at Groenakker. The assessment is prepared under Groenakker’s ISO 13485:2016 certified quality system and signed by a DABT board-certified toxicologist, and issued in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Derivation of TI and EEDmax (GRK-2004) for anything above the screening limit; the additional material literature search (GRK-1004) where the biological evaluation also needs material-level support; and chemical characterisation or a ChemTox package where the theoretical assessment does not close the endpoint.
