Medical Devices

Biocompatibility and toxicology risk assessment capabilities:

Biological risk assessments, evaluation plans, gap analyses and reports, in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971;

Design and preparation of in vivo and in vitro studies related to all biocompatibility development activities;

Evaluation of chemistry data following extractable and leachable testing;

Toxicological risk assessments and determination of appropriate margins of safety;

Proficient in the use of threshold levels (TTC) in association with ISO TS21726 and production of mitigations and derive contingencies for the presence of contaminants/impurities/extractables;

Can act as the single point of contact in monitoring and coordinating outsourced studies.

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