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Cytotoxicity Score Zero

What If…. I Fail Cytotoxicity

Cytotoxicity is a biocompatibility test that every single medical device and material needs to undergo during its development. It is a critical test to ensure that your device or the materials in your device do not cause cell death or inhibit cell growth. So, what happens if your device fails this crucial first test?

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Risk Assessment Formula

Threshold of Toxicological Concern

The Threshold of Toxicological Concern (TTC) is a pragmatic risk assessment tool and is considered to be an exposure level below which the risk of adverse effects to human health is expected to be negligible.  TTC values for a given compound can be derived using its molecular structure to determine the hazard ranking based on the Cramer classification. 

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GLP Practices

What are the GLPs?

In the United States, Good Laboratory Practice, aka “the GLPs”, describes FDA regulation 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. This regulation is for in vivo or in vitro experiments where test articles (such as medical devices, biological products, pharmaceutical products, or any other article subject to regulation under the Food, Drug, and [...] Full Story
Sample Preparation

Proper Sample Preparation for Biocompatibility Testing

Sample preparation is one of the most critical steps in a preclinical testing program for a medical device. This initial step is often overlooked or unclear to sponsors, and if not thoroughly strategized up-front, can lead to unnecessary delays or unfavorable results in testing programs.

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