Cytotoxicity testing can be used to test a sample to determine how much it can damage, or even cause the death of, human cells. Standards and legislation require manufacturers to demonstrate that their devices are not cytotoxic. With a good test setup, it is possible to detect whether a sample is 100% cytotoxic, i.e., highly cytotoxic, or…
DetailsThe 510(k), also known as “Premarket Notification”, is one of the most common procedures for the authorization of medical devices in the USA. The concept is based on demonstrating equivalence with a predicate device (equivalent device). But the same mistakes, which can result in the entire 510(k) authorization failing, are made time and again. It…
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