Achieve a better understanding of biological safety evaluation and answer questions related to what you should be doing as a device manufacturer to comply with FDA guidance while keeping your overall program costs manageable. 

This white paper proposes a test method that addresses FDA expectations, practical considerations, and inherent limitations of the canine thrombogenicity test.

By Christopher Parker, M.S., M.B.A.

Amid efforts at harmonization, important differences exist between U.S./FDA/ISO and Ministry of Health, Labour, and Welfare (Japan) medical device biocompatibility requirements.

By Laxman Desai, D.Sc. and Laurence Lister

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