Advisory Services

The biological evaluation plan is where a programme starts.

The Biological Evaluation Report is the document that closes out the plan.

An add-on rather than a standalone service: this extends an existing biological evaluation plan or report to cover one additional contact category, with its own endpoint set assessed on its own terms.

A structured search of the published toxicological literature for one additional material, produced to support the endpoint justification in your biological evaluation.

A device, material or process change assessed for its effect on the existing biological evaluation — and, most importantly, for whether it forces re-testing.

The per-constituent arithmetic behind an ISO 10993-17 assessment: a tolerable intake and a maximum estimated exposure dose derived for one constituent from the available toxicological data.

The gas pathway risk assessment turns ISO 18562 analytical data into a safety conclusion.

The toxicological risk assessment is the step that turns chemistry into a safety conclusion.

A toxicological risk assessment for a device with no extractables and leachables data — built from material composition, supplier data and published toxicology, with the residual uncertainty stated rather than hidden.