Cytotoxicity testing is one of the most commonly used methods for evaluating the biological safety of medical devices. However, delays in regulatory approval, confusion over the right testing approach, and repeated reworks due to failed cytotoxicity assays are the kinds of setbacks that stall timelines, inflate budgets, and limit progress. Uncertainty around sample sizes, extraction methods, and the right assay for your material or indication often compounds the challenge.

Eurofins Medical Device Services network of laboratories offers deep technical expertise, end-to-end project support, and cutting-edge assay platforms to help you avoid these issues and move forward with confidence. With 30+ years of experience in biological safety testing and a track record of ISO 10993-5 and USP <87> compliance, we provide fast, flexible cytotoxicity testing tailored to your device and submission strategy. We also interpret results and identify sources of test failures, provide toxicological risk assessments for failed assays, and deliver clear reporting that supports submission-ready documentation.

As both a critical screening tool and a key biological endpoint for regulatory submissions, cytotoxicity assesses a material’s potential to inhibit cell growth or cause cell death. These in vitro assays, performed using either qualitative or quantitative methods, provide a rapid yet sensitive analysis of the biological reactivity of leachables or diffusible substances. Eurofins Medical Device Services network of laboratories applies validated cell culture techniques—shown to correlate well with animal assays—to support the safe development of medical devices used in or on the human body. The appropriate test method is selected based on the sample’s nature, intended site, and conditions of use. We’ll work with you to select the right test system based on the device’s density, extractability, and intended use.