Medical Devices
How We Can Help
ToxEssential can help identify gaps in the available data and recommend steps to mitigate them. In cases where additional testing is required, ToxEssential can design the required study, select expert laboratories, and ensure the reports meet ISO 10993 requirements and Regulatory standard. We focus on in vitro and in vivo biological testing, chemical characterization and toxicological risk assessments which aligns with Regulatory Agencies' expectation worldwide.
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What We Do
Biocompatibility testing and safety evaluation according to ISO 10993 for medical devices.
Drafting of Medical Device Master File (MAF) toxicology section.
Chemical characterization of medical devices including extractables & leachables toxicological assessment and study design according to ISO 10993-18.
Toxicological risk assessment of medical devices and tolerable intake determination.
