New Alternatives

The process by which medical devices are evaluated for biocompatibility is undergoing an exciting change; one in which New Approach Methods (NAMs), like the use of toxicological risk assessment, computational modeling, and in vitro test methods, are being developed as alternatives to traditionally used methods that largely rely on the results of animal testing to predict the safety of devices in patients.

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Risk Science Consortium, LLC

Although testing in animals continues to play an important role in the safety assessment of some devices, especially for implanted devices, it is increasingly recognized that tests to assess biological endpoints like carcinogenicity, reproductive toxicity, and systemic toxicity are expensive, time consuming, use large numbers of animals, and sometimes fail to provide results that are predictive of the response of patients to the device.

Toxicologists at the Risk Science Consortium, LLC can help clients to develop safety evaluation strategies that involve new, less burdensome approaches to assess the biocompatibility of their devices; approaches that are more patient-centric, predictive of real-world device performance and, importantly, are likely to be accepted by regulatory agencies as a means to evaluate the biological safety of their device.

Our website outlines our areas of expertise and provides information on training courses and White Papers available on the use of toxicological risk assessment to evaluate the safety of extractable and leachable (E&L) compounds.