Cytotoxicity is one of the most common assays performed as a part of medical device biocompatibility assessments. It is also very sensitive, and as a result many medical device companies find themselves having to handle positive cytotoxicity results with their products. These results need to be addressed, though they should be treated as a question that needs to be answered rather than a definitive flaw in the product. It may indeed be possible to demonstrate that the device in question is safe in its intended use despite the cytotoxicity results. Join us as we explore how to approach these cases and, when possible, make a safety case for a device despite positive cytotoxicity results.
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