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Testing Service Category: Medical Device

Toxicological Risk Assessment

Understanding Risk Assessment The pathway to regulatory approval for medical products can be lengthy and expensive. Based on the FDA Biocompatibility Guidelines, it is essential to conduct your safety testing […]

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Surgical Research

Uniquely Equipped to Assist in the Development of Tomorrow’s Lifesaving Medical Devices and Drugs Toxikon’s Department of Efficacy and Surgical Research Services is uniquely equipped to assist in the development […]

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Stability Testing

Understanding Stability Testing Services Leachables studies want to follow the migration behavior of any material impurity being introduced into the drug product as a result of the interaction with the […]

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Pathology Testing Services

Understanding Pathology Testing Services Toxikon’s pathologist’s skills and expertise in comparing morphologic changes with biological phenomena puts us at the forefront of assisting sponsors in tissue assessment. These groups are […]

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Ocular Studies

Understanding Customized Ocular Studies for Targeted Therapeutics Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. Our experienced study directors will provide you with […]

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Microbiology Testing

Understanding Microbiology Testing Services Microbiological characterization of medical devices typically accompany regulatory submissions and bioburden, endotoxin, and tests for sterility are common requirements. These tests are performed according to USP […]

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Medical Device Cleaning Validation

Validating the Efficacy of SOPs and IFUs for Reusable Medical Devices Medical devices in this category must have adequate labeling and directions for use (21 CFR Part 801) related to […]

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Extractables & Leachables Testing

Related services USP Compendial Testing | Biocompatibility Testing | Toxicological Assessments | Chemical Characterization Understanding Extractables Extractables are compounds that migrate from the contact surface under more aggressive conditions, such as elevated temperature, […]

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Disease Models

Understanding Disease Models Disease models are cells that display some or all of the pathological processes observed in an actual animal or human disease. Toxikon’s team of experts provide expertise […]

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Compendial Testing

Pharmacopoeial Testing Services Compendial Testing Standards US (CMC) and European (CTD) submissions often need to contain Certificates of Analysis (CoA) to prove compliance of the materials to the current US […]

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