Toxicology Services

Toxicology Assessment

Toxicological Risk Assessments

Although toxicological risk assessment is somewhat of a niche science, it plays an important role in establishing the safety of medical devices. The significance of this activity has increased tremendously over the last few years. The biocompatibility assessment of medical devices continues to evolve in line with changes to regulatory thinking and advances in the capabilities of scientific and technical assessments. With the latest revisions of ISO 10993 -18:2020 and EU MDR, there is a substantial focus on the material and chemical characterization of medical devices. A robust toxicological risk assessment can replace time-consuming, expensive animal toxicity studies for regulatory agency submission and approval. A qualified toxicologist or experienced professional must review the information from materials, testing or other scientific data to make an informed decision. Our scientists are highly skilled experts and subject matter specialists with professional board certifications in regulatory and toxicology work. We work closely with the client to meet the requirements set in international standards and guidelines to support patient safety for medical devices.

We offer a wide array of toxicology services, including:

Hazard-based Risk Assessments

• Evaluation of medical products, materials of construction (including additives, processing aids, color additives, etc.), and manufacturing process changes.
• Assistance with selection of materials in early stages of product development.

Exposure-based Risk Assessments

• Review information from extractables and/or leachables testing, etc.

Biological Testing Support

• Develop test plans for supporting individual medical devices, considering the device category (surface-contact, implant, blood-contact, etc.) and/or material type (polymer, bioresorbable, nanomaterial, etc.).
• Critically review existing ISO 10993 biological endpoint testing results (cytotoxicity, irritation, sensitization, implantation, acute/sub-acute/sub-chronic/chronic studies, developmental & reproductive toxicity, genotoxicity, carcinogenicity studies, etc.) to identify any gaps, including recommendations for additional endpoint testing outside of the standard matrix, (e.g., toxicokinetics, immunotoxicity or other organ-specific toxicities).
• Provide comprehensive written summaries of all available data in support of biocompatibility suitable for regulatory submission.

Chemical Characterization Support

• Conduct literature searches in relevant toxicity databases to collect information regarding any material and compound related hazards, identify point-of-departures, and develop dose-response reviews to derive allowable limits for medical devices.
• Provide toxicological inputs for the design of degradation or extractables studies (including suitable sample and solvent selection, analytical evaluation threshold, etc.

Evaluation of Biological Equivalence

• Comparison of a new device or device material to a clinically established one.

Our Toxicology Services

Our regulatory scientists have extensive global regulatory experience. We have biological safety experts who can provide toxicological support including planning and designing studies and conducting toxicological risk assessments on an as needed basis. Whether it’s a simple material change, evaluation of a novel material, or an elaborate biological safety test, our experts can help you determine your regulatory path to approval.