Advisory Services

A Biological Evaluation Plan to ISO 10993-1:2025: the risk-based document that categorises your device, identifies every patient-contacting material, sets the endpoints to be addressed and decides — before anything is ordered — which are met by testing, which by literature and existing data, and which can be justified away.

A Biological Evaluation Report to ISO 10993-1:2025: the document that closes the evaluation by gathering every test result, literature justification and existing dataset against the endpoints set in the plan, and states the biological safety conclusion for the device.

Evaluation of one additional patient-contacting category under ISO 10993-1:2025, extending a biological evaluation plan or report to a second contact type or duration — for example a device that contacts both intact skin and circulating blood.

A structured literature search and endpoint-risk evaluation for one additional patient-contacting material, extending the five materials included in the base Biological Evaluation Plan.

Assessment of a device, packaging or manufacturing change against an existing biological evaluation, using the ISO 10993-1 decision framework, concluding whether the change affects biocompatibility and what, if anything, needs to be re-tested.

Full toxicological evaluation, per constituent, of compounds found above the toxicological screening limit: estimated exposure dose (EEDmax), tolerable intake (TI) and margin of safety (MOS) derived under ISO 10993-17:2023 by a board-certified toxicologist.

A toxicological risk assessment for a gas pathway device to ISO 18562-1:2024: emission data from ISO 18562-2 and -3 testing interpreted into inhaled dose, with dose-based thresholds derived for up to 25 compounds or compound groups above the analytical evaluation threshold.

A toxicological risk assessment to ISO 10993-17:2023 of your chemical characterisation data: constituents identified and grouped, screened against US and EU restricted-substance lists, and assessed against the toxicological screening limit — with TI and margin-of-safety derivation for anything above it quoted per constituent.

A toxicological risk assessment to ISO 10993-17:2023 for a device with no extractables and leachables data, built from material formulations, safety data sheets and the substances that touch the device in manufacturing — theoretical worst-case exposure compared with the toxicological screening limit.