Today’s medical device manufacturers face unprecedented challenges and opportunities while looking at the impacts of globalization, rapidly evolving technologies, and emerging areas of science. These impacts require medical device companies who already have or are looking to enter the global marketplace to continuously employ cutting-edge Toxicology and Biocompatibility sciences to assess the safety and effectiveness of their regulated products and meet the stringent global requirements.
The scientific disciplines of Toxicology and Biocompatibility are essential to global certification.  To reach compliance with global requirements companies today need to employ a Toxicology and Biocompatibility specialist or subject matter expert (Ph.D./DABT), experienced with Toxicological Risk Assessment (TRA), ISO 10993-18 Chemical Characterization of Materials and Biological Evaluation test plans and summaries.  A company today needs to make sure all risk impacts are assessed because if missed it could cost the company millions.

We specialize in Project-based solutions and consulting engagements and have a team of Toxicologists and Biocompatibility subject matter experts ready to support you and your team.

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