How can you get ahead of complex biocompatibility challenges in medical device development?
Building on years of development support in a wide range of medical devices, Exponent's biocompatibility and biological risk assessment experts are equipped to assess and test the new generation of implantable and tissue-engineered medical devices that control biological interactions with pharmacological agents, bioactive coatings, and/or nano-enabled materials to improve safety and efficacy.
Many of these combination drug or biologic devices are creating new regulatory challenges as companies pursue Food and Drug Administration and EU Medical Device Regulation compliance when seeking product clearance or approval. With our device and combination products expertise, Exponent is uniquely qualified to perform biocompatibility and biological risk assessments of medical devices and materials for a range of needs and help you address compatibility risks during device development.
Evaluating the biocompatibility of a biomaterial is typically addressed by testing outlined in FDA guidance documents and ISO 10993 biocompatibility standards. We offer customized analytical chemistry testing and subsequent toxicological risk assessments in accordance with ISO 10993, as well as 21 CFR Part 58 good laboratory practices.
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