Advisory Services

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 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.