In vitro diagnostics, and medical devices in general, must perform their therapeutic or diagnostic function without causing adverse effects, such as cytotoxicity, irritation, sensitisation, toxicity, or thrombogenicity.
We offer biocompatibility testing for in vitro diagnostics (IVDs), including extract preparation referenced to ISO 10993-12 and cytotoxicity testing referenced to ISO 10993-5. Where your evaluation needs other endpoints, we can evaluate and make recommendations for the best fit with your biological evaluation plan.